Technique Guide. Universal Spinal System (USS). Designed to achieve the goals of scoliosis surgery.

Transcription

1 Technique Guide Universal Spinal System (USS). Designed to achieve the goals of scoliosis surgery.

2 Table of Contents Introduction Universal Spinal System 2 AO ASIF Principles of Internal Fixation 3 Indications 4 Surgical Technique Hook Placement 5 Preparing the Pedicle 7 Inserting the Screw 10 Contouring the Rod 12 Assembling the Construct 14 Distraction and Compression 17 Tightening the Construct 19 Technique Options Attaching Transconnector 22 Attaching Transconnector Clamp to Rod 23 Attaching Transverse Bars 25 Attaching the Open Transverse Bar 26 Attaching the Closed Transverse Bar 28 Reduction Procedure for Spondylolisthesis 30 Anterior Approach 31 Product Information Implants Sets 48 Sterilization Parameters 48 Image intensifier control Synthes Spine

3 Universal Spinal System Goals of Scoliosis Surgery Correct sagittal and coronal alignment Restore balance in the spine Prevent further progression of deformity Fuse the fewest number of vertebral segments Protect the spinal cord The Universal Spinal System is designed to achieve the goals of scoliosis surgery. The system is based upon: Independent anchorage of hooks and/or screws to the spine and independent rod positioning Simple connection between the implant and the rod Segmental correction and stabilization Features and Benefits Low-profile system Side-opening, top-tightening construct Simplifies intraoperative procedure Requires no implant preloading onto rod Single Core Screws offered in titanium and stainless steel (Fig. 1) Dual Core Screws offered in titanium (Fig. 2) Technique adaptability Designed to correct scoliosis by segmental correction or global derotation. Versatile linkage mechanism Allows addition or removal of anchorage points to an assembled construct. Fig. 1 Single Core Fig. 2 Dual Core 2 Synthes Spine Universal Spinal System

4 AO ASIF Principles of Internal Fixation The AO ASIF Principles of Internal Fixation In 1958, the AO ASIF (Association for the Study of Internal Fixation) formulated four basic principles, 1 which have become the guidelines for internal fixation. They are: Anatomical reduction Stable internal fixation Preservation of blood supply Early, active pain-free mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural elements. 2 AO ASIF Principles as Applied to the Spine 3 Anatomical Alignment Restoration of normal spinal alignment to improve the biomechanics of the spine. Stable Internal Fixation Stabilization of the spinal segment to promote bony fusion. Preservation of Blood Supply Creation of an optimal environment for fusion. Early, Pain-Free Mobilization Minimization of damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient. 1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger: AO Manual of Internal Fixation, 3rd Edition. Berlin; Springer-Verlag Ibid. 3. M. Aebi, J.S. Thalgott, and J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer-Verlag Synthes Spine 3

5 Indications Posterior Components The Synthes Universal Spinal System (USS) devices are noncervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 S2), a posterior hook fixation system (T1 L5) or as an anterolateral fixation system (T8 L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Synthes Small Stature USS. The Synthes USS devices are indicated for all of the following regardless of the intended use: degenerative disc disease (defined as discogenic back pain with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), Scheuermann s Disease, tumor, stenosis, pseudoarthrosis, and failed previous fusion. In addition, the Synthes USS is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5 S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to lumbar and sacral spine with removal of the implants after the attainment of solid fusion. When used with the 3.5 mm/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix System. Also, the Synthes USS can be interchanged with all USS 6.0 mm rods and transconnectors. Anterior Components The anterior components of the Synthes USS are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis and fracture or dislocation of the thoracolumbar spine (T8 L5). Please refer to product insert GP0001 for complete system description, indications and warnings. 4 Synthes Spine Universal Spinal System

6 Hook Placement 1 If necessary, prepare lamina for lamina hook Instrument Lamina Finder Small Lamina Finder (with silicone handle) Medium Lamina Finder (with silicone handle) Large Lamina Finder (with silicone handle) Use the appropriate Lamina Finder to separate the ligamentum flavum from the underside of the lamina to ensure good bony contact with the lamina hook. The Lamina Finder can be used to prepare for down-going or up-going lamina hooks. 2 If necessary, prepare pedicle for pedicle hook Instrument Pedicle Finder Pedicle Finder (with silicone handle) Use the Pedicle Finder to open the facet capsule and locate the pedicle. Remove a small piece of the inferior articular process to ensure proper seating of the pedicle hook. An osteotome can be used to remove a small piece of the inferior articular process. This allows proper seating of the Pedicle Hook (up-going). Synthes Spine 5

7 Hook Placement continued 3 Place hook Hook or Screw Holder ( Stick ) Handle for Hook or Screw Holder Hook Positioner Hook Positioner (with silicone handle) Align the Hook or Screw Holder ( Stick ) with the appropriate hook, and secure. Snap the Stick into the Handle for Hook or Screw Holder by depressing the button on the handle. Place the hook in the desired location. The Hook Positioner may also be used to facilitate placement of the hook. After the hook is properly seated, remove the handle. The Stick can remain attached to the hook Synthes Spine Universal Spinal System

8 Preparing the Pedicle for Screw Placement 1 Identify the pedicle The entry point for each lumbar pedicle is at the intersection of a horizontal line bisecting the transverse process and a vertical line drawn along the lateral border of the superior articular process. The point of entry for each thoracic pedicle is at the intersection of a line through the transverse process and a line through the inferolateral edge of the facet joint. Synthes Spine 7

9 Preparing the Pedicle for Screw Placement continued 2 Prepare the pedicle Thoracic Pedicle Probe, 3 mm width at tip (with silicone handle) Pedicle Probe with Palm Handle for 4.0 mm and 4.2 mm Screws (with silicone handle) Pedicle Probe for 7.0 mm, 8.0 mm, and 9.0 mm screws Probe for 5.0 mm and 6.0 mm screws Pedicle Probe for 4.0 mm and 4.2 mm screws Awl (for 5.0 mm 9.0 mm screws) Awl, for 4.0 mm and 4.2 mm screws Probe with Palm Handle for 5.0 mm 9.0 mm screws (with silicone handle) Awl with Palm Handle for 4.0 mm 9.0 mm screws (with silicone handle) Use the appropriate awl to perforate the posterior cortex of the pedicle (Figure 1). Figure 1 Figure 2 Open the pedicle canal using the appropriate probe (Figure 2). Displace the soft cancellous bone by advancing the probe through the pedicle canal into the vertebral body. Use radiographic imaging to check position and orientation. Important: Care should be taken not to perforate the walls of the pedicle. Note: Additionally available Pedicle Markers can be used to confirm position and orientation using radiographic imaging. 8 Synthes Spine Universal Spinal System

10 3 Select proper screw length Straight Ball Tip Probe Curved Ball Tip Probe Ball Tip Probe Palpate the walls of the pedicle and determine the depth of the pedicle canal using a ball tip probe. This instrument has depth markings at 25 mm, 30 mm, 40 mm, 50 mm, 60 mm and 70 mm. Synthes Spine 9

11 Inserting the Screw 4 Insert screws Hook/Screw Holder ( Stick ) Handle for Hook/Screw Holder Insert the Stick into the appropriate side-opening screw and secure with the coupling screw. Snap the Stick into the Handle by depressing the button on the handle. Insert the side-opening screw into the prepared pedicle. After the screw has been inserted, remove the handle by depressing the button, leaving the Stick in place, if desired. 10 Synthes Spine Universal Spinal System

12 Optional Methods of Screw Insertion Screwdriver Screwdriver Shaft Holding Sleeve for Long Small Hexagonal Screwdriver Holding Sleeve (for , and ) The Screwdriver for side-opening implants may also be used for screw insertion. The Holding Sleeve may be used with either the screwdriver or the screwdriver shaft to retain the screw during initial insertion into the pedicle. Either the Ratchet Handle and Screwdriver Shaft, or the Handle and the Stick, can be used to facilitate screw insertion. The metal ring on the Ratchet Handle may be positioned in a clockwise, counterclockwise or neutral position: mm Hexagonal Screwdriver, long (with silicone handle) Hook or Screw Holder ( Stick ) Handle for Hook or Screw Holder Ratchet T-Handle Screwdriver, for side-opening implants (with silicone handle) Position Clockwise Counterclockwise Neutral Function Screw insertion Screw removal Nonratcheting or Synthes Spine 11

13 Contouring the Rod 1 Determine rod contour Coated Rod Template for 6.0 mm rod, 150 mm Coated Rod Template for 6.0 mm rod, 500 mm When the screws and hooks have been placed and their position confirmed radiographically, determine the contour of the rod by using the appropriate 6.0 mm Coated Rod Template. 2 Cut rod to length (if necessary) Rod Cutter Table Top Rod Cutter Handheld Rod Cutter Adjust the rod length using the Rod Cutter, the Table Top Rod Cutter, or the Handheld Rod Cutter. All rod cutting should take place outside the operative field. 12 Synthes Spine Universal Spinal System

14 3 Contour the rod Bending Irons, left and right In Situ Benders, right and left Rod Bender Rod Bender Coronal Benders, left and right , Use the Rod Bender or the Bending Irons to contour the rod to match the rod template. Use the knob on the Rod Bender to adjust the bend radius. Use the Bending Irons, Coronal Benders or In Situ Benders for in situ rod bending. Synthes Spine 13

15 Assembling the Construct 1 Introduce the rod Rod Holding Forceps Rod Pusher Rod Pusher (with silicone handle) Rod Holding Forceps with Clamp Grip Position the rod parallel to the side opening of the screws and hooks using the Rod Holding Forceps or Rod Holding Forceps with Clamp Grip. Introduce the rod into the side-opening screw or hook using the Rod Pusher. 2 Apply the collars and the nuts Socket Wrench with straight handle, 11 mm Socket Wrench with Straight Handle, 11 mm (with silicone handle) Stacked nut and collar Load a Collar and Nut into the 11 mm Socket Wrench. Note that the collar can be loaded in only one direction. Place the instrument over the head of the implant and seat both the collar and the nut. Tighten the nut using the Socket Wrench. 14 Synthes Spine Universal Spinal System

16 Optional Method for Assembling the Construct Assembly using the Persuader Rod Introduction Pliers, for side-opening implants ( Persuader ) Hook or Screw Holder ( Stick ) Use the Persuader with the Stick for construct assembly. The Persuader has a specialized holding sleeve that enables a collar to be preloaded and retained in the correct orientation. 1 Load collar Load a collar onto the barrel of the Persuader. Note: The collar can be loaded in only one direction. Collar Synthes Spine 15

17 Optional Method for Assembling the Construct continued 2 Engage rod Distraction Forceps, curved (for 6.0 mm rods) Distraction Clip Position the barrel of the Persuader over the Stick and advance it downward over the implant. Engage the rod with the jaws opposite the barrel of the Persuader and squeeze the handle to insert the rod into the hook or screw. If biplanar reduction of the rod is necessary, use the Distraction Clip and the Distraction Forceps with the Persuader to guide the rod into the hook or screw opening. The Distraction Forceps allow manipulation of the construct to achieve the desired sagittal-plane contour. Place the Distraction Clip over the Stick to allow reduction. Use the Distraction Forceps against the Distraction Clip while squeezing the Persuader until the rod is seated in the hook or screw. 3 Seat collar Hook Positioner (with silicone handle) Socket Wrench with L-handle, 11 mm Socket Wrench with straight handle, 11 mm Hook Positioner Socket Wrench with Straight Handle, 11 mm (with silicone handle) Use the Hook Positioner to tap the collar onto the implant assembly. Once the collar is pushed down over the implant, remove the Distraction Clip and the Persuader. Place a Nut over the construct and tighten it with the Socket Wrench. 16 Synthes Spine Universal Spinal System

18 Distraction and Compression 1 Determine point of fixation Rod Holding Forceps Half Ring Titanium Half Ring Rod Holding Forceps with Clamp Grip Use the Rod Holding Forceps or a Half Ring as a point of fixation, if necessary, against which to distract or compress. 2 If distraction is required Parallel Distraction Forceps Socket Wrench with straight handle, 11 mm Distraction Forceps, curved (for 6.0 mm rods) Socket Wrench with Straight Handle, 11 mm (with silicone handle) Use the Distraction Forceps and ensure the nut is loose before distracting against the point of fixation. Once in the desired position, tighten the nut using the Socket Wrench. Synthes Spine 17

19 Distraction and Compression continued 3 If compression is required Parallel Compression Forceps Socket Wrench with straight handle, 11 mm Compression Forceps Socket Wrench with Straight Handle, 11 mm (with silicone handle) Use the Compression Forceps and ensure the nut is loose before compressing against the point of fixation (Figure 3). Once in the desired position, tighten the nut using the Socket Wrench (Figure 4). Figure 3 Figure 4 4 If derotation is required Socket Wrench with straight handle, 11 mm Socket Wrench with Straight Handle, 11 mm (with silicone handle) Rod Rotation Wrench, for 6.0 mm hexagonal-end Rods Make certain that all nuts are loose. Grasp the rod with the Rod Holding Forceps and slowly rotate in the proper direction. Alternatively, the Rod Rotation Wrench is available for rotating hex end rods. Once in the desired position, tighten the nut using the Socket Wrench. 18 Synthes Spine Universal Spinal System

20 Provisional Tightening of the Construct Methods for Provisional Tightening Option 1 Tightening using the screwdriver for countertorque Socket Wrench with L-Handle, 11 mm Socket Wrench with straight handle, 6 mm Screwdriver, for side-opening implants Screwdriver, for side-opening implants (with silicone handle) Socket Wrench with Straight Handle, 6 mm (with silicone handle) Place the Screwdriver (without holding sleeve) through the Socket Wrench with L-Handle. Hold the Screwdriver stationary as countertorque while turning the L-handle wrench to secure the nut. Application of countertorque reduces the torque on the bone while tightening the nut. Note: Any distraction or compression must be completed before final tightening. The 10 Nm Torque Wrench must be used for final construct tightening. Synthes Spine 19

21 Provisional Tightening of the Construct continued Option 2 Tightening using the Internal Counter Torque Socket Wrench with L-Handle, 11 mm Internal Counter Torque Insert the Internal Counter Torque into the Socket Wrench with L-Handle to reduce torque on the bone while tightening the nut. Hold the Internal Counter Torque stationary and turn the Socket Wrench with L-Handle to secure the nut. Note: Any distraction or compression must be completed before final tightening. The 10 Nm Torque Wrench must be used for final construct tightening. Option 3 Tightening using the 6 mm Socket Wrench with Straight Handle for countertorque Socket Wrench with L-Handle, 11 mm Socket Wrench with straight handle, 6 mm Hook or Screw Holder ( Stick ) Socket Wrench with Straight Handle, 6 mm (with silicone handle) Place the Socket Wrench with L-Handle over the Hook or Screw Holder and insert the 6 mm Socket Wrench with Straight Handle. Hold the straight handle wrench stationary and turn the L-Handle wrench to secure the nut. Note: Any distraction or compression must be completed before final tightening. The 10 Nm Torque Wrench must be used for final construct tightening. 20 Synthes Spine Universal Spinal System

22 Final Tightening Option 1 The 10 Nm Torque Wrench must be used for final construct tightening Nm Torque Wrench, 11 mm width across flats Internal Counter Torque Place the Torque Wrench over the nut. Insert the Internal Counter Torque into the wrench. Hold the Internal Counter Torque stationary while turning the Torque Wrench. The wrench will click at the preset torque of 10 Nm. Option 2 The 10 Nm Torque Wrench and Counter Torque Sleeve can also be used for final construct tightening Nm Torque Wrench, 11 mm width across flats Counter Torque Sleeve Place the Counter Torque Sleeve over the screw or hook head. Insert the 10 Nm Torque Wrench into the Counter Torque Sleeve. Hold the Counter Torque Sleeve stationary while turning the 10 Nm Torque Wrench. The wrench will click at the preset torque of 10 Nm. Synthes Spine 21

23 Technique Options Attaching Transconnector 1 Measure distance between rods Instrument Measuring Template, for Low Profile Transconnectors The Low Profile Transconnector is used as a construct stabilizer to reduce rotation. Use the Measuring Template to measure the distance between the two rods and determine the appropriate transconnector length. 2 Secure transconnector to rods Long Small Hexagonal Screwdriver mm Hexagonal Screwdriver, long (with silicone handle) Loosen all of the setscrews and place the appropriate length Low Profile Transconnector onto the rods. Use the Hexagonal Screwdriver to secure the transconnector to the rods by tightening the setscrews on each end. When using an adjustable length transconnector, adjust the distance between the rods, if desired, by compressing or distracting. Then, tighten the center setscrew on the rotating shaft using the Hexagonal Screwdriver. Notes: For transconnectors with angular adjustment, tighten the stargrind setscrew to lock the angle between the rods. If any part of the construct requires further adjustment, all transconnector setscrews must be loosened. After final adjustment, retighten the setscrews. 22 Synthes Spine Universal Spinal System

24 Attaching Transconnector Clamp to Rod Long Small Hexagonal Screwdriver Holding Sleeve for and mm Hexagonal Screwdriver, long (with silicone handle) Use a USS Preassembled Transconnector Clamp or an Transconnector Clamp (composed of a unassembled clamp body and collar) to provide additional rotational stability. 1 Attach clamp to screwdriver When assembling the transconnector clamp, place the transconnector collar over the holding sleeve on the hexagonal screwdriver. Insert the hexagonal screwdriver into the clamp body setscrew and slide the holding sleeve down to secure the clamp body to the screwdriver. 2 Attach clamp to rod Place the clamp body onto the 6.0 mm rod and slide the collar down to attach the clamp body to the rod. Synthes Spine 23

25 Technique Options continued 3 Determine length of 3.5 mm bar Instrument Coated Rod Template Use the Coated Rod Template to determine the length of the 3.5 mm bar and cut the bar to length with a Rod Cutter. 4 Insert the 3.5 mm bar Instrument Bar Holding Forceps Use the Bar Holding Forceps to insert the 3.5 mm bar into the bar channel located below the setscrew. Ensure that the bar channel, collar cutout and setscrew allow bar insertion. The 3.5 mm bar can be adjusted ± 20 with respect to the clamp. 20 Repeat the procedure on the contralateral side. 5 Tighten the setscrews Tighten the setscrews in both clamp bodies with the Hexagonal Screwdriver to secure the construct. 24 Synthes Spine Universal Spinal System

26 Attaching Transverse Bars The Universal Spinal System offers both Open Transverse Bars (Figure 5) and Closed Transverse Bars (Figure 6) for implantto-rod attachment. The transverse bar acts as a lateral extension to the hook or screw in situations where the rod contour or patient anatomy prevents direct hook- or screw-to-rod connection. The transverse bar permits variation in the sagittal angulation of the implant along the 6.0 mm rod (Figure 7). The sagittal and axial alignment can be achieved independently of each other. Figure 5 The transverse bar also allows medial/lateral displacement of the hook or screw from the 6.0 mm rod and rotation of the implant around the 6.0 mm rod (Figure 8). The bar lengths are 15 mm, 20 mm, 25 mm and 30 mm. Figure 6 Figure 7 Figure 8 Synthes Spine 25

27 Technique Options continued Attaching the Open Transverse Bar 1 Attach clamp to screwdriver Long Small Hexagonal Screwdriver Holding Sleeve for and mm Hexagonal Screwdriver, long (with silicone handle) The Open Transverse Bar can be used after the construct has already been secured. The Open Transverse Bar consists of two implants: the Clamp for Open Transverse Bar and the Open Transverse Bar. Note: A frontal hook must be used with a transverse bar. Attach the Clamp for Open Transverse Bars to the hexagonal screwdriver with holding sleeve by engaging the setscrew of the clamp with the holding sleeve. 2 Place clamp on rod Place the opening of the Open Transverse Bar on top of the 6.0 mm rod. Position the Clamp for Open Transverse Bars to straddle the Open Transverse Bar. Note: If the transverse bar is placed below the 6.0 mm rod, rotate the clamp to straddle the rod when securing the bar to the rod. 26 Synthes Spine Universal Spinal System

28 3 Tighten the setscrew Long Small Hexagonal Screwdriver Holding Sleeve for and mm Hexagonal Screwdriver, long (with silicone handle) Rod Crimping Pliers Rod Introduction Pliers, for side-opening implants ( Persuader ) mm Hexagonal Screwdriver, long (with silicone handle) Introduce the transverse bar into the frontal hook or sideopening screw with the Rod Crimping Pliers or Persuader. Tighten the setscrew on the clamp with the Long Small Hexagonal Screwdriver. Proceed with step 5 on page 29. Synthes Spine 27

29 Technique Options continued Attaching the Closed Transverse Bar The Closed Transverse Bar is used when it can be preloaded onto the rod, particularly when the hook or screw cannot be easily aligned with the rod. Note: A frontal hook must be used with a transverse bar. 1 Attach bar to screwdriver Long Small Hexagonal Screwdriver Holding Sleeve for and mm Hexagonal Screwdriver, long (with silicone handle) Attach the Closed Transverse Bar to the hexagonal screwdriver with holding sleeve by engaging the setscrew of the transverse bar with the holding sleeve. 2 Place bar on rod Place the Closed Transverse Bar on the 6.0 mm rod. 3 Align bar to screw or hook Use the hexagonal screwdriver with holding sleeve to align the transverse bar with the screw or frontal hook. 28 Synthes Spine Universal Spinal System

30 4 Attach transverse bar Rod Crimping Pliers Rod Introduction Pliers, for side-opening implants ( Persuader ) Introduce the transverse bar into the frontal hook or sideopening screw with the Rod Crimping Pliers or Persuader. Tighten the setscrew on the transverse bar to secure it in position. 5 Place collar and nut Place the 6 mm Collar with grooves over the screw or frontal hook. Place a Nut over the Stick and tighten using the 11 mm Socket Wrench. Synthes Spine 29

31 Technique Options continued Reduction Procedure for Spondylolisthesis Parallel Distraction Forceps Distraction Forceps, curved (for 6.0 mm rods) Rod Holding Forceps Rod Introduction Pliers ( Persuader ) Distraction Clip Rod Holding Forceps with Clamp Grip Position a Distraction Clip or Rod Holding Forceps on the knurling of the Stick. Place Distraction Forceps between the Distraction Clip or the Rod Holding Forceps and the barrel of the Persuader. Slowly squeeze the Distraction Forceps and the Persuader to reduce the spondylolisthesis. 30 Synthes Spine Universal Spinal System

32 Anterior Approach Staples and washers can be used to provide secure anchorage for anterolateral constructs. 1 Insert staple Staple Impactor Staple Impactor (with silicone handle) Position the staple on the anterolateral aspect of the thoracolumbar spine to accommodate optimal screw placement. Drive the tips through the cortical bone and seat the staple using the Staple Impactor and a small mallet. 2 Washers Place the washer over the screw. Use the other implants (rod, collars, and nuts) to complete the construct. Synthes Spine 31

33 Implants Hooks Low-profile design Side-opening design allows rod attachment to side of the hook Multiple designs for use around the lamina, pedicle or transverse process Specialized lamina hooks for thoracic and lumbar applications Frontal hooks for attachment to the transverse bar 13.5 mm Pedicle Hook Lamina Hook Thoracic Lamina Hook Transverse Process Hook Collars and Nuts Secure screws and hooks to the 6.0 mm rod Collars capture the rod, yet allow longitudinal adjustments along the rod before tightening 11 mm nuts secure the construct Screws Low-profile design Side-opening design simplifies intraoperative rod-to-screw assembly Both screw types are self-tapping Available in stainless steel or titanium single core, single lead design of 4.2 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm and 9.0 mm diameters, in lengths ranging from 25 mm to 140 mm (Fig.1) Available in titanium dual core, single lead design of 4.0 mm, 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm and 9.0 mm diameters, in lengths ranging from 25 mm to 100 mm (Fig.2) Dual core screws with rounded tips promote safe screw insertion Fig. 1 Single Core Fig. 2 Dual Core 32 Synthes Spine Universal Spinal System

34 Rods Available in 6.0 mm diameter Hard and soft rods are available for system versatility 50 mm to 500 mm lengths in 50 mm increments Hex end rod in 500 mm length also available Transverse Bars Provide a lateral extension from the 6.0 mm rod to the hook or screw Eliminate the need for severe rod contouring, which might otherwise be required for direct hook- or screwto-rod connection Used with screws and front-opening hooks Available in lengths of 15 mm, 20 mm, 25 mm and 30 mm Parallel Connectors The 6.0 mm /6.0 mm connector extends USS constructs The 5.0 mm /6.0 mm connector allows attachment to the Small Stature USS. The 3.5 mm /6.0 mm connector allows attachment of the USS to the CerviFix System 6.0 mm /6.0 mm 5.0 mm /6.0 mm 3.5 mm /6.0 mm Synthes Spine 33

35 Implants continued Low Profile Transconnector Links both rods, providing the construct with rotational stability Clamp body and collar of transconnector assembly allows 20 of angulation Preassembled for ease of placement Available in four fixed lengths (15 mm, 18 mm, 21 mm and 24 mm) and eight adjustable lengths (25.5 mm 83 mm) Stargrind allows attachment to non-parallel rods Adjustable length Center shaft allows 45 rotation about the horizontal axis. Fixed length Stargrind Transconnector Assemblies Links both rods to provide the construct with rotational stability Available in configurations shown to the right Clamp body and collar of the transconnector assemblies permit 20 of angulation Rod available in 3.5 mm diameter, 80 mm and 120 mm length Staples and Washers Provide secure anchorage for anterolateral constructs in the thoracolumbar spine Sizes for use with 5.0 mm, 6.0 mm, 7.0 mm and 8.0 mm screws 34 Synthes Spine Universal Spinal System

36 for Hook Placement Pedicle Finder Lamina Finder Hook or Screw Holder ( Stick ) Hook Positioner Synthes Spine 35

37 for Hook Placement continued Lamina Finders Small Medium Large Hook Positioner Handle for Hook or Screw Holder Pedicle Finder 36 Synthes Spine Universal Spinal System

38 for Pedicle Preparation Awl for 4.0 mm and 4.2 mm screws Awl (for 5.2 mm 9.0 mm screws) Awl with Palm Handle (for 4.0 mm 9.0 mm screws) Pedicle Probe for 4.0 mm and 4.2 mm screws Probe (for 5.0 mm and 6.0 mm screws) Pedicle Probe for 7.0 mm, 8.0 mm, and 9.0 mm screws Pedicle Probe with Palm Handle for 4.0 mm and 4.2 mm screws Probe with Palm Handle (for 5.0 mm 9.0 mm screws) Thoracic Pedicle Probe (3 mm width at tip) Synthes Spine 37

39 for Pedicle Preparation continued Straight Ball Tip Probe Curved Ball Tip Probe Ball Tip Probe Taps for Dual Core Screws, single lead, 6 mm hex coupling for 4.0 mm screws for 5.0 mm screws for 6.0 mm screws for 7.0 mm screws for 8.0 mm screws for 9.0 mm screws Cannulated Tap for Dual Core Screws, single lead, 6 mm hex coupling for 4.0 mm screws for 5.0 mm screws for 6.0 mm screws for 7.0 mm screws for 8.0 mm screws for 9.0 mm screws 38 Synthes Spine Universal Spinal System

40 for Screw Insertion Hook or Screw Holder ( Stick ) Handle for Hook or Screw Holder Screwdriver, for side-opening implants Holding Sleeve (for , and ) Screwdriver, for side-opening implants For alternative method of screw insertion Screwdriver Shaft for side-opening screws Ratchet T-Handle, 6 mm hex coupling Synthes Spine 39

41 for Rod Contouring Coated Rod Templates for 6.0 mm rod mm mm Rod Cutter Rod Bender, with bend radius adjustment Bending Iron, left Bending Iron, right Rod Bender with radius adjustment and spring opening 40 Synthes Spine Universal Spinal System

42 Coronal Rod Bender, left Coronal Rod Bender, right In Situ Bender, right In Situ Bender, left Rod Holding Forceps, for 6.0 mm rods Rod Holding Forceps, with Clamp Grip Synthes Spine 41

43 for Construct Assembly Rod Pusher, for 6.0 mm rods Rod Pusher (with silicone handle) Collar Impactor Collar Impactor (with silicone handle) Socket Wrench with straight handle, 6 mm Socket Wrench with Straight Handle, 6 mm (with silicone handle) 42 Synthes Spine Universal Spinal System

44 Socket Wrench with straight handle, 11 mm Socket Wrench with Straight Handle, 11 mm (with silicone handle) Socket Wrench with L-Handle, 11 mm Rod Introduction Pliers ( Persuader ), for side-opening implants Distraction Clip Rod Crimping Pliers, for side-opening implants Synthes Spine 43

45 for Distraction and Compression Distraction Forceps, curved (for 6.0 mm rods) Reinforced instrument jaws provide strength and rigidity for optimal transfer of distraction force to the implants Compression Forceps (for 6.0 mm rods) Reinforced instrument jaws provide strength and rigidity for optimal transfer of compression force to the implants Parallel Distraction Forceps Parallel Compression Forceps Parallel Compressor with Extended Travel, for 6 mm rods Rod Holding Forceps, for 6.0 mm rods Ensures consistent and stable grip on rod with ratchet locking mechanism 44 Synthes Spine Universal Spinal System

46 Rod Holding Forceps with Clamp Grip Titanium Half Ring Half Ring Rod Rotation Wrench, for 6.0 mm hexagonal-end rods Synthes Spine 45

47 for Tightening of Construct Nm Torque Wrench, 11 mm width across flats Important: For final tightening of the construct, this wrench must be used to apply the proper amount of torque Internal Counter Torque Counter Torque Sleeve Hook or Screw Holder ( Stick ) Handle for Hook or Screw Holder Screwdriver Shaft, for side-opening screws Ratchet T-Handle 46 Synthes Spine Universal Spinal System

48 for Attaching Transconnector Long Small Hexagonal Screwdriver Holding Sleeve, for Long Small Hexagonal Screwdriver mm Hexagonal Screwdriver, long Bar Holding Forceps, for 3.5 mm bar Measuring Template, for Low Profile Transconnectors for 6.0 mm rods for anterior approach Staple Impactor Staple Impactor (with silicone handle) Synthes Spine 47

49 Titanium Dual Core USS Hook, Rod and Clamp Implant Set ( ) Graphic Case Hook, Rod and Clamp Implant Set Graphic Case Implants Side-Opening Hooks Titanium Description Qty Lamina Hook, small, right Lamina Hook, small, left Lamina Hook, small, frontal Lamina Hook, medium, right Lamina Hook, medium, left Lamina Hook, medium, frontal Lamina Hook, large, right Lamina Hook, large, left Lamina Hook, large, frontal Thoracic Lamina Hook, right Thoracic Lamina Hook, left Thoracic Lamina Hook, frontal Pedicle Hook, right Pedicle Hook, left Pedicle Hook, frontal Transverse Process Hook, right Transverse Process Hook, left Transverse Process Hook, frontal, right Transverse Process Hook, frontal, left mm Hard Rods Titanium Length (mm) Qty mm Hexagonal-end Rods Titanium Length (mm) Qty Sterilization Parameters for Set ( ) These Synthes sets with all additionally available items, as marked in the case, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Cycle Temperature Exposure Time Steam Prevacuum C 10 Minutes (Wrapped) ( F) Steam Gravity Displacement C 28 Minutes (Wrapped) ( F) 48 Synthes Spine Universal Spinal System

50 Implants continued Collar, Nut Titanium Description Qty Collar with grooves Nut, 11 mm 36 Half Ring Titanium Description Qty Half Ring 4 Low Profile Transconnectors for 6.0 mm Rods Titanium Length (mm) Qty mm Bars, for Transconnector Titanium Length (mm) Qty Clamps Titanium Description Qty Clamp for Open Transverse Bars USS Preassembled Transconnector Clamp 4 Parallel Connectors Titanium Diameters (mm/mm) Qty / / / Closed Transverse Bars Titanium Length (mm) Qty Open Transverse Bars Titanium Length (mm) Qty Instrument Measuring Template Synthes Spine 49

51 Titanium Dual Core USS Screw Implant Set ( ) Graphic Case Graphic Case for Dual Core USS Screw Implant Set Implants Dual Core USS Screws Thread Diameter Length Titanium (mm) (mm) Qty mm 20 mm mm 25 mm mm 28 mm mm 30 mm mm 32 mm mm 35 mm mm 38 mm mm 40 mm mm 45 mm mm 25 mm mm 30 mm mm 35 mm mm 40 mm mm 45 mm mm 50 mm mm 55 mm mm 25 mm mm 30 mm mm 35 mm mm 40 mm mm 45 mm mm 50 mm mm 55 mm mm 60 mm mm 65 mm mm 25 mm mm 30 mm mm 35 mm mm 45 mm mm 50 mm mm 55 mm mm 60 mm mm 65 mm mm 70 mm 2 Sterilization Parameters for Set ( ) This Synthes set with all additionally available items, as marked in the case, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Cycle Temperature Exposure Time Steam Prevacuum C 10 Minutes (Wrapped) ( F) Steam Gravity Displacement C 28 Minutes (Wrapped) ( F) 50 Synthes Spine Universal Spinal System

52 Dual Core USS Screws continued Thread Diameter Length Titanium (mm) (mm) Qty mm 75 mm mm 80 mm mm 90 mm mm 100 mm mm 25 mm mm 30 mm mm 35 mm mm 40 mm mm 45 mm mm 50 mm mm 55 mm mm 60 mm mm 65 mm mm 70 mm mm 75 mm mm 80 mm mm 90 mm mm 100 mm mm 30 mm mm 35 mm mm 40 mm mm 45 mm mm 50 mm mm 55 mm mm 60 mm mm 65 mm mm 70 mm mm 75 mm mm 80 mm mm 90 mm mm 100 mm 2 Washers For screw Outer diameter diameter Titanium (mm) (mm) Qty Small Staples Titanium Description Qty for 5 mm screws for 6 mm screws for 7 mm screws 4 Synthes Spine 51

53 Dual Core USS Screw and Hook Instrument Set ( ) Graphic Case Graphic Case for USS Hook and Screw Holding Sleeve for Holding Sleeve for Hook or Screw Holder, 16 ea Small Lamina Finder Medium Lamina Finder Large Lamina Finder Hook Positioner Screwdriver Shaft, for side-opening implants mm Hexagonal Screwdriver, long, 2 ea Pedicle Probe with Palm Handle, for 4.0 mm and 4.2 mm screws Straight Ball Tip Probe Curved Ball Tip Probe Handle, for Hook or Screw Holder, 2 ea Ratchet T-Handle Probe with Palm Handle (for 5.0 mm 9.0 mm screws) Awl with Palm Handle (for 4.0 mm 9.0 mm screws) Screwdriver, for side-opening implants Thoracic Pedicle Probe, 3 mm width at tip Pedicle Finder Taps for Dual Core Screws, single lead, 230 mm for 4.0 mm screws for 5.0 mm screws for 6.0 mm screws for 7.0 mm screws for 8.0 mm screws for 9.0 mm screws Cannulated Taps for Dual Core Screws, single lead, 230 mm for 4.0 mm screws for 5.0 mm screws for 6.0 mm screws for 7.0 mm screws for 8.0 mm screws for 9.0 mm screws 52 Synthes Spine Universal Spinal System

54 Dual Core USS Rod Instrument Set ( ) Graphic Cases Graphic Case for USS Deformity Correction Graphic Case for USS Rod Bending Graphic Case for Additional USS Deformity in Graphic Case Socket Wrench with L-Handle Rod Crimping Pliers Rod Introduction Pliers, 2 ea Nm Torque Wrench Counter Torque Sleeve Internal Counter Torque Distraction Clip, 2 ea Socket Wrench with Straight Handle, 11 mm, 2 ea. in Graphic Case In Situ Bender, right In Situ Bender, left Rod Pusher for 6.0 mm rod Coated Rod Template Coated Rod Template Rod Bender with radius adjustment and spring opening Coronal Rod Bender for 6.0 mm Rod, left Coronal Rod Bender for 6.0 mm Rod, right Rod Holding Forceps with Clamp Grip, 2 ea Rod Rotation Wrench, for 6.0 mm hexagonal-end rods in Graphic Case Parallel Distraction Forceps Parallel Compression Forceps Staple Impactor Socket Wrench with Straight Handle, 6 mm Collar Impactor Sterilization Parameters for Sets ( and ) These Synthes sets with all additionally available items, as marked in the case, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Cycle Temperature Exposure Time Steam Prevacuum C 10 Minutes (Wrapped) ( F) Steam Gravity Displacement C 28 Minutes (Wrapped) ( F) Synthes Spine 53

55 Universal Spinal System Hook, Rod and Clamp Sets Stainless Steel ( ) and Titanium ( ) Graphic Case USS Hook and Rod Set Graphic Case Implants Side-Opening Hooks Stainless Steel Titanium Description Qty Lamina Hook, small, right Lamina Hook, small, left Lamina Hook, small, frontal Lamina Hook, medium, right Lamina Hook, medium, left Lamina Hook, medium, frontal Lamina Hook, large, right Lamina Hook, large, left Lamina Hook, large, frontal Thoracic Lamina Hook, right Thoracic Lamina Hook, left Thoracic Lamina Hook, frontal Pedicle Hook, right Pedicle Hook, left Pedicle Hook, frontal Transverse Process Hook, right Transverse Process Hook, left Transverse Process Hook, 2 frontal, right Transverse Process Hook, 2 frontal, left 6.0 mm Hard Rods Stainless Steel Titanium Length (mm) Qty Sterilization Parameters for Sets ( and ) These Synthes sets with all additionally available items, as marked in the case, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Cycle Temperature Exposure Time Steam Prevacuum C 10 Minutes (Wrapped) ( F) Steam Gravity Displacement C 28 Minutes (Wrapped) ( F) 54 Synthes Spine Universal Spinal System

56 Implants continued Collar, Nut Stainless Steel Titanium Description Qty Collar with grooves Nut, 11 mm 20 Half Ring Stainless Steel Titanium Description Qty Half Ring 4 Low Profile Transconnectors for 6.0 mm Rods Stainless Steel Titanium Length (mm) Qty mm Bars, for Transconnector Stainless Steel Titanium Length (mm) Qty Clamps Stainless Steel Titanium Description Qty Clamp for Open Transverse Bars USS Preassembled Transconnector Clamp 4 Parallel Connectors Stainless Steel Titanium Diameters (mm/mm) Qty / / / Closed Transverse Bars Stainless Steel Titanium Diameter (mm) Qty Open Transverse Bars Stainless Steel Titanium Diameter (mm) Qty Instrument Measuring Template Synthes Spine 55

57 Universal Spinal System Screw Sets Stainless Steel ( ) and Titanium ( ) Graphic Case USS Screw Set Graphic Case Implants Side-Opening Screws Stainless Diameter Length Steel Titanium (mm) (mm) Qty Washers For screw Outer Stainless diameter diameter Steel Titanium (mm) (mm) Qty Small Staples Stainless Steel Titanium Description Qty for 5 mm screws for 6 mm screws for 7 mm screws 4 Sterilization Parameters for Sets ( and ) These Synthes sets with all additionally available items, as marked in the case, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Cycle Temperature Exposure Time Steam Prevacuum C 10 Minutes (Wrapped) ( F) Steam Gravity Displacement C 28 Minutes (Wrapped) ( F) 56 Synthes Spine Universal Spinal System

58 Universal Spinal System Hook and Screw Instrument Set ( ) Graphic Case USS Hook and Screw Instrument Set Graphic Case Long Small Hexagonal Screwdriver, 2 ea Screwdriver, for side-opening implants Screwdriver Shaft, for side-opening screws Holding Sleeve for , 2 ea Holding Sleeve for Pedicle Probe, for 7.0 mm, 8.0 mm and 9.0 mm screws Probe (for 5.0 mm and 6.0 mm screws) Pedicle Probe, for 4.0 mm and 4.2 mm screws Straight Ball Tip Probe Curved Ball Tip Probe Pedicle Finder Lamina Finder Awl (for 5.0 mm 9.0 mm screws) Awl for 4.0 mm and 4.2 mm screws Hook or Screw Holder, 16 ea Handle, for Hook or Screw Holder, 2 ea Hook Positioner Ratchet T-Handle, 6 mm hex coupling Ball Tip Probe Sterilization Parameters for Sets ( and ) These Synthes sets with all additionally available items, as marked in the case, can be sterilized by the following parameters. For more information, please refer to graphic case package insert. Method Cycle Temperature Exposure Time Steam Prevacuum C 10 Minutes (Wrapped) ( F) Steam Gravity Displacement C 28 Minutes (Wrapped) ( F) Synthes Spine 57

59 Universal Spinal System Rod Instrument Set ( ) Graphic Case USS Rod Instrument Set Graphic Case Staple Impactor Socket Wrench with L-handle, 11 mm Socket Wrench with straight handle, 6 mm Socket Wrench with straight handle, 11 mm, 2 ea Nm Torque Wrench, 11 mm Counter Torque Sleeve Internal Counter Torque Distraction Forceps, curved Compression Forceps Rod Holding Forceps, for 6.0 mm rod, 2 ea Bar Holding Forceps, for 3.5 mm bar Rod Crimping Pliers, for side-opening implants Rod Introduction Pliers, for side-opening implants Distraction Clip Coated Rod Template for 6.0 mm rod, 150 mm Coated Rod Template for 6.0 mm rod, 500 mm Bending Iron, left Bending Iron, right Rod Pusher, for 6.0 mm Rods Rod Bender, with bend radius adjustment Collar Impactor 58 Synthes Spine Universal Spinal System

60 Also Available (Dual Core) For set Tall Body Lamina Hooks Titanium Description Small, left Small, right Small, frontal Medium, left Medium, right Medium, frontal Large, left Large, right Large, frontal Extended Blade Lamina Hooks Small, left Small, right Small, frontal Medium, left Medium, right Medium, frontal Large, left Large, right Large, frontal Tall Body Extended Blade Lamina Hooks Small, left Small, right Small, frontal Medium, left Medium, right Medium, frontal Large, left Large, right Large, frontal Rectangular Opening Lamina Hooks mm, right mm, left mm, right mm, left mm, right mm, left mm, right mm, left 6.0 mm Hard Rods Titanium mm Soft Rods Length (mm) 6.0 mm Rods (Ti-6Al-7Nb) Transconnector Implants Titanium Description Transconnector Clamp Body Transconnector Collar For set Washers For screw Outer diameter diameter Titanium (mm) (mm) Staples Titanium Description for 5 mm screws for 6 mm screws for 7 mm screws for 8 mm screws Synthes Spine 59