HydraLok. Operative Technique. Polyaxial Pedicle Screw System

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1 HydraLok Operative Technique Polyaxial Pedicle Screw System

Table of Contents Introduction...1 OPERATIVE TECHNIQUE OVERVIEW.

..4 PROBE THE PEDICLE...4 ENSURE THE INTEGRITY OF THE PEDICLE WALL.

..5 LOAD POLYAXIAL SCREW...5 REDUCTION SCREWS...6 ROD SELECTION.

..6 DEROTATION, COMPRESSION AND DISTRACTION (OPTIONAL).

2 Table of Contents Introduction...1 OPERATIVE TECHNIQUE OVERVIEW...2 DETAILED OPERATIVE TECHNIQUE...4 LOCATE AND PREPARE THE PEDICLE...4 PROBE THE PEDICLE...4 ENSURE THE INTEGRITY OF THE PEDICLE WALL...4 GUIDE PIN INSERTION (OPTIONAL)...4 TAPPING (OPTIONAL)...5 LOAD POLYAXIAL SCREW...5 REDUCTION SCREWS...6 ROD SELECTION...6 ROD BENDER...6 ROD PLACEMENT AND TIGHTENING...6 ROD REDUCTION...6 DEROTATION, COMPRESSION AND DISTRACTION (OPTIONAL)...7 Counter TORQUE AND FINAL TIGHTENING...7 CROSS CONNECTOR PLACEMENT...7 implant Listing...8 instrument listing...9 Indications for Use...13

3 Introduction HydraLok Polyaxial Pedicle Screw System is a 6.0mm top-loading system that includes screws, rods and connectors that may be used in the thoracic, lumbar and sacral spine. HydraLok offers a complete range of titanium color-coded pedicle screws from 5.0mm to 8.0mm and 35mm to 55mm lengths. The 360-degree head rotation and 45-degree screw angulation allow for easy rod placement with minimal contouring. The system also features self-tapping screws that are designed to save valuable time in the operating room. 1

4 OPERATIVE TECHNIQUE OVERVIEW 1 Establish Pedicle Entry Point 2 Probe the Pedicle Ensure Integrity of Pedicle Wall 3 4 4a Mark the Pedicle 5 Tap the Pedicle 6 Load Pedicle Screw 2

5 7 Insert Polyaxial Screw 8 Place Rod and Tighten 9 Derotate Rod 10 Compression/Distraction and Final Tightening 11 Apply Cross Connectors 12 Final Tightening of Cross Connectors 3

6 DETAILED OPERATIVE TECHNIQUE LOCATE AND PREPARE THE PEDICLE Identify the pedicle and the entry hole location. The pedicle is typically located at the intersection of the superior articulate facet and the midline of the transverse process. Create an entry hole for the pedicle screw by using the Bone Awl to puncture the cortex. With the Bone Awl, penetrate the cortex by using a downward twisting force (Figure 1). Figure 1 Establish Pedicle Entry Point PROBE THE PEDICLE The Straight or Curved Pedicle Probe is used to create the screw path through the pedicle and into the vertebral body. Both of these instruments include depth markings at the tip of the instrument (Figure 2). ENSURE THE INTEGRITY OF THE PEDICLE WALL After the pedicle has been cannulated, the pedicle may now be sounded. Using the Straight Tester, verify the integrity of the interior pedicle walls by palpating the cephalad edge, the medial wall and the inferior edge as well as the deepest portion of the opening (Figure 3). GUIDE PIN INSERTION (OPTIONAL) Guide Pins are available and may be inserted to confirm the pedicle location under visualization if desired (Figure 4, 4a). Figure 2 Probe the Pedicle Figure 3 Ensure Integrity of Pedicle Wall Figure 4 Mark the Pedicle Figure 4a Mark the Pedicle 4

The Taps are downsized approximately.5mm to provide an interface for the Screw.

7 Figure 5 Tap the Pedicle Figure 6 Load Pedicle Screw TAPPING (OPTIONAL) All Polyaxial Screws are self-tapping. If pretapping is desired, Taps are available in various sizes that correspond to the diameters of the Polyaxial Screws. The Tap that is used must match the size of the Polyaxial Screw that is desired. The Taps are downsized approximately.5mm to provide an interface for the Screw. Attach the appropriately sized Tap to the Straight or Ratcheting T-Handle and proceed to tap the Screw entry hole by rotating the handle clockwise. The Depth Gauge may be used to determine Screw length (Figure 5). LOAD POLYAXIAL SCREW After determining the appropriate Screw length, attach the Reversible Polyaxial Screwdriver into the inner hexalobe of the Screw and lock it by rotating the central locking wheel clockwise. Note: It is important to note that there are two configurations for the Reversible Polyaxial Screwdriver. Use the small Reversible Drive Shaft for 5, 6 and 7mm screws and the Large Reversible Drive Shaft for the 7.5 and 8.0 Screws (Figure 6). INSERT POLYAXIAL SCREW Figure 7 Insert Polyaxial Screw into Vertebral Body The Polyaxial Screws may now be inserted into pedicle to the pre-determined depth. Turn the Reversible Polyaxial Screwdriver clockwise to insert the Screw (Figure 7). Once the Screw is fully inserted, disengage the Screw from the Reversible Polyaxial Screwdriver by turning the central locking wheel counterclockwise. Repeat the steps for all remaining Pedicle Screws. 5

REDUCTION SCREWS If necessary, Reduction Polyaxial Screws are also available and can be inserted using the Reversible Reduction Polyaxial Screwdriver corresponding to the desired screw size.

8 REDUCTION SCREWS If necessary, Reduction Polyaxial Screws are also available and can be inserted using the Reversible Reduction Polyaxial Screwdriver corresponding to the desired screw size. The small Reversible Polyaxial Screwdriver is inserted into the Screw tulip and tightened by rotating the central locking wheel clockwise. ROD SELECTION After the Polyaxial Screws have been placed, the desired length of the rod should be selected. The Curved Rods are in pre-cut lengths ranging from 40mm to 110mm. The Straight Rods are available in pre-cut lengths ranging from 120mm to 480mm. ROD BENDER The French Rod Bender is primarily used for curving or bending Straight Rods. If needed, it can also be used to increase or decrease the lordosis in the Curved Rod. Figure 8 Place Rod and Tighten The degree of lordosis can be varied by adjusting the center button. A small, medium or large radius may be selected by pulling out the large center knob while rotating the knob as desired. The Rod should seat fully into the tulip of the Pedicle Screw. Note: In Situ Benders may also be used to bend the Rod once it is placed within the construct. ROD PLACEMENT AND TIGHTENING After the Rod has been contoured as desired, it is then placed into the Polyaxial Screw housing with the Curved or Straight Rod Holder (Figure 8). The Polyaxial Screw allows up to 45 degrees of angulation. Once the Rod has been placed, load a set screw onto the Twist Tip Set Screwdriver and provisionally tighten each screw. Figure 9 Derotate Rod ROD REDUCTION To assist with the reduction of the Rod into the Screw, several instruments are available. 1. The Rod Pusher helps to persuade the Rod into the Screw head, without capturing the Screw head. 2. The Pistol Grip Rod Persuader is inserted over the Rod and Screw, and the Ratcheting Handle allows the Rod to be slowly reduced. 3. The Cylinder Style Rod Persuader is used to fully capture the Polyaxial Screw head in place, while the Ratcheting Handles reduce the Rod. After the Rod is fully reduced into the Screw head, it can be provisionally tightened using the Set Screw Starter as described above. 6

Figure 10 Compression/Distraction and Final Tightening DEROTATION, COMPRESSION AND DISTRACTION (OPTIONAL) After all of the Set Screws have been provisionally inserted into the Screw housing, the

While the Rod is held in place with the De-rotator, the Set Screws are tightened using the Set Screwdriver attached to the T-Handle Torque Limiting Driver.

9 Figure 10 Compression/Distraction and Final Tightening DEROTATION, COMPRESSION AND DISTRACTION (OPTIONAL) After all of the Set Screws have been provisionally inserted into the Screw housing, the De-rotator may be used to rotate the contoured Rod into the desired position (Figure 9). While the Rod is held in place with the De-rotator, the Set Screws are tightened using the Set Screwdriver attached to the T-Handle Torque Limiting Driver. The Compressor or Distractor can also be used to apply final compression or distraction to the construct. Once the desired compression or distraction is accomplished, the Set Screws can be tightened using the Set Screwdriver attached to the T-Handle Torque Limiting Driver (Figure 10). Figure 11 Apply Cross Connector Counter TORQUE AND FINAL TIGHTENING After any desired derotation, compression and distraction have been performed; the Set Screwdriver should be attached to the T-Handle Torque Limiting Driver and inserted through the Counter Torque for final tightening of the Set Screws (Figure 10). The Set Screw should be rotated clockwise until the arrows on the torque indicator are aligned with one another, indicating the necessary torque has been applied. CROSS CONNECTOR PLACEMENT A Cross Connector may now be used if desired. Cross Connectors are available in sizes ranging from 30 to 40mm in 5mm increments and in 40 to 70mm in 10mm increments. The Cross Connector is attached to the longitudinal rods either by hand or by using the Cross Connector Nut Starter. The Crosslink Nut Starter snaps around the arm of the Cross Connector underneath the connector nut (Figure 11). This leaves the nut and rod clamp portion of the Connector free to rotate for proper positioning over the construct. Figure 12 Final Tightening of Cross Connector The Connector is pushed down until the rod clamp mechanism clicks onto the rod. Once positioned onto both rods, the Cross Connector Torque Limiting Wrench is connected to the Nut Driver and inserted through the Cross Connector Counter Torque to tighten all the nuts. The Torque Limiting Wrench should be rotated clockwise until the Handle clicks indicating that the necessary torque has been applied (Figure 12). 7

implant Listing Catalog Number Part Description Cross Connectors 28220 28221 28222 28223 28224 Cross Connector, 30mm-35mm Cross Connector, 35mm-40mm Cross Connector,

0mm x 40mm Curved Rod, 6.0mm x 50mm Curved Rod, 6.0mm x 60mm Curved Rod, 6.0mm x 70mm Curved Rod, 6.0mm x 80mm Curved Rod, 6.0mm x 90mm Curved Rod, 6.

0mm x 480mm Set Screws 28301 28202 Set Screws, 5.0mm, 6.0mm and 7.0mm Set Screws, 7.5mm and 8.

10 implant Listing Catalog Number Part Description Cross Connectors Cross Connector, 30mm-35mm Cross Connector, 35mm-40mm Cross Connector, 40mm-50mm Cross Connector, 50mm-60mm Cross Connector, 60mm-70mm Curved Rods Curved Rod, 6.0mm x 40mm Curved Rod, 6.0mm x 50mm Curved Rod, 6.0mm x 60mm Curved Rod, 6.0mm x 70mm Curved Rod, 6.0mm x 80mm Curved Rod, 6.0mm x 90mm Curved Rod, 6.0mm x 100mm Curved Rod, 6.0mm x 110mm Straight Rods Straight Rod, 6.0mm x 120mm Straight Rod, 6.0mm x 200mm Straight Rod, 6.0mm x 480mm Set Screws Set Screws, 5.0mm, 6.0mm and 7.0mm Set Screws, 7.5mm and 8.0mm Reduction Screws PS60040R PS60045R PS60050R PS70040R PS70045R PS70050R Reduction Polyaxial Screw, 6.0mm x 40mm Reduction Polyaxial Screw, 6.0mm x 45mm Reduction Polyaxial Screw, 6.0mm x 50mm Reduction Polyaxial Screw, 7.0mm x 30mm Reduction Polyaxial Screw, 7.0mm x 45mm Reduction Polyaxial Screw, 7.0mm x 50mm 8

Catalog Number Part Description Polyaxial Screws PS50035 PS50040 PS50045 PS50050 PS60035 PS60040 PS60045 PS60050 PS60055 PS70035 PS70040 PS70045 PS70050 PS70055 PS75035 PS75040 PS75045 PS75050

11 Catalog Number Part Description Polyaxial Screws PS50035 PS50040 PS50045 PS50050 PS60035 PS60040 PS60045 PS60050 PS60055 PS70035 PS70040 PS70045 PS70050 PS70055 PS75035 PS75040 PS75045 PS75050 PS75055 PS80035 PS80040 PS80045 PS80050 PS80055 Polyaxial Screw, 5.0mm x 35mm Polyaxial Screw, 5.0mm x 40mm Polyaxial Screw, 5.0mm x 45mm Polyaxial Screw, 5.0mm x 50mm Polyaxial Screw, 6.0mm x 35mm Polyaxial Screw, 6.0mm x 40mm Polyaxial Screw, 6.0mm x 45mm Polyaxial Screw, 6.0mm x 50mm Polyaxial Screw, 6.0mm x 55mm Polyaxial Screw, 7.0mm x 35mm Polyaxial Screw, 7.0mm x 40mm Polyaxial Screw, 7.0mm x 45mm Polyaxial Screw, 7.0mm x 50mm Polyaxial Screw, 7.0mm x 55mm Polyaxial Screw, 7.5mm x 35mm Polyaxial Screw, 7.5mm x 40mm Polyaxial Screw, 7.5mm x 45mm Polyaxial Screw, 7.5mm x 50mm Polyaxial Screw, 7.5mm x 55mm Polyaxial Screw, 8.0mm x 35mm Polyaxial Screw, 8.0mm x 40mm Polyaxial Screw, 8.0mm x 45mm Polyaxial Screw, 8.0mm x 50mm Polyaxial Screw, 8.0mm x 55mm instrument listing Straight Probe Curved Probe Straight Tester Guide Pin Driver Guide Pin Guide Pin, Grooved Depth Gauge 9

HYDRALOK instrument Listing Catalog Number

12 HYDRALOK instrument Listing Catalog Number Part Description Hydralok 5.0mm Tap HydraLok 6.0mm Tap HydraLok 7.0mm Tap HydraLok 7.5mm Tap HydraLok 8.0mm Tap mm Hex Driver mm Hex Driver Straight Rod Holder Rod Pusher Curved Rod Holder De-rotator French Rod Bender Distractor Compressor 10

Catalog Number Part Description 28277 Modular Straight

Polyaxial Driver Assay 28281-1 28281-2 Small Driver, 5.0-7.

0mm screws 28282 T-Handle and Torque Limiting Driver 28285

Left In Situ Bender, Right 05-059-00-0000 Counter Torque,

05-059-03-0000 Cross Connector Torque Limiting Driver

13 Catalog Number Part Description Modular Straight Handle Modular T-Handle Ratchet T-Handle Polyaxial Driver Assay Small Driver, mm screws Large Driver, 7.5mm and 8.0mm screws T-Handle and Torque Limiting Driver Counter Torque Head Positioner In Situ Bender, Left In Situ Bender, Right Counter Torque, Cross Connector Cross Connector Nut Driver Cross Connector Torque Limiting Driver Handle Curved Probe Small Polyaxial Driver Assembly 11

Catalog Number Part Description 05-059-42-0000 Bone Awl 05-059-44-0000 Large Polyaxial Pedicle

05-059-47-0000 Persuader, Pistol Grip 05-059-48-0000 Persuader, Cylinder Style 05-059-49-0000

#1 05-059-04-0006 HydraLok 5.0mm Pedicle Screw Caddy 05-059-04-0007 HydraLok 6.

14 Catalog Number Part Description Bone Awl Large Polyaxial Pedicle Screw Driver Cross connector Nut Starter Crosslink Nut Driver Persuader, Pistol Grip Persuader, Cylinder Style Yoke Manipulator Tap Breaker, Reduction Screw HydraLok Implant Tray # HydraLok 5.0mm Pedicle Screw Caddy HydraLok 6.0mm Pedicle Screw Caddy HydraLok 7.0mm Pedicle Screw Caddy HydraLok 7.5mm Pedicle Screw Caddy 12

0mm Cross Connector Caddy 10-121-00-0001 Double Height Outer Cast 10-301-05-0001 Outer Case Lid Indications for Use GENERAL DESCRIPTION The HydraLok System is a top-loading spinal fixation

The components are manufactured from titanium alloy (Ti-6AI-4V ELI as described by ASTM F136). The HydraLok System components are provided clean and non-sterile.

$instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation,$ scoliosis, kypohsis, spinal tumor and failed previous fusion (pseudoarthrosis).

scoliosis, kypohsis, spinal tumor and failed previous fusion (pseudoarthrosis).

15 HydraLok 8.0mm Pedicle Screw Caddy HydraLok Implant Tray # HydraLok Reduction Pedicle Screw Caddy HydraLok Set Screw Caddy HydraLok 6.0mm Cross Connector Caddy Double Height Outer Cast Outer Case Lid Indications for Use GENERAL DESCRIPTION The HydraLok System is a top-loading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar and sacral spine. Various sizes of the implants are provided. The components are manufactured from titanium alloy (Ti-6AI-4V ELI as described by ASTM F136). The HydraLok System components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use. INDICATIONS FOR USE The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kypohsis, spinal tumor and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion. CONTRAINDICATIONS Contraindications for the HydraLok System are similar to those of other systems of similar design, and include, but are not limited to: Active infectious process in the patient, particularly in or adjacent to the spine or spinal structures Morbid obesity 13 (continued on back)

16 Indications for Use (cont.) Pregnancy Grossly distorted anatomy (e.g., congenital abnormalities) and bone abnormalities (e.g., bone absorption, osteopenia, or osteoporosis) preventing safe screw fixation Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery Suspected or documented metal allergy or intolerance WARNINGS AND PRECAUTIONS The HydraLok System should only be implanted by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. In addition, based on the fatigue test results, the surgeon should consider the levels of implantation, patient weight, patient activity level, and other patient conditions (e.g., smoking, occupation), which may impact on the performance of the system. Due to the presence of implants, interference with roentgenographic, CT, and/or MR imaging will result. The HydraLok System has not been evaluated for safety and compatibility in the MR environment. The HydraLok System has not been tested for heating or migration in the MR environment. Preoperative A successful result is not achieved in every surgical case, especially in spinal surgery where many extenuating circumstances may compromise results. Preoperative planning and operating procedures, including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are critical considerations in achieving a successful result. Only patients that meet the criteria described in the indications should be selected. Patient conditions and/or predispositions such as those mentioned in the contraindications should be avoided. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. Care should be used in the handling and storage of the implant components. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage, especially from corrosive environments. The type of construct to be assembled for the case should be determined prior to beginning the surgery. An adequate inventory of sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used. Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the devices to verify that all parts and necessary instruments are present before the surgery begins. All components and instruments must be cleaned and sterilized prior to use. Additional sterile components should be available in case of unexpected need. Intraoperative The surgeon should follow established practices and specific instructions for implant of the system. Contouring or bending of a screw may reduce its fatigue strength and cause failure under load. If screws are bent or damaged during insertion or adjustment, they may not be implanted and must be replaced. Rods should only be contoured with the proper contouring instruments. Incorrectly contoured rods or rods which have been repeatedly or excessively contoured should not be implanted. Bone grafts must be placed in the area to be fused. Some degree of corrosion occurs on all implanted metal and alloys. Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in building a construct. Different manufacturers use different materials, varying tolerances and design configurations. Components of the HydraLok System must not be used with components from any other system or manufacturer. Postoperative The physician's post-operative directions and warnings to the patient and the corresponding patient compliance are extremely important. Detailed instructions on the use and limitations of the device should be given to the patient. The patient should be instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. Patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent restriction in body motion. The patient should be advised not to smoke or consume alcohol during the bone graft healing process. If a non-union develops or the components loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue these stresses can cause eventual bending, loosening or breakage of the device(s). Any decision to remove the implants should take into consideration the risk to the patient of additional surgeries, as well as the difficulty of removal. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, none of the HydraLok System components should be reused under any circumstances. Exactech is proud to have offices and distributors around the globe. For more information about Exactech products available in your country, please visit For additional device information, refer to the Exactech Spine Instructions for Use for a device description, indications, contraindications, precautions and warnings. For further product information, please contact Customer Service, Exactech, Inc., 2320 NW 66th Court, Gainesville, Florida , USA. (352) , (800) or FAX (352) The products discussed herein may be available under different trademarks in different countries. All copyrights, and pending and registered trademarks, are property of Exactech, Inc. This material is intended for the sole use and benefit of the Exactech sales force and physicians. It should not be redistributed, duplicated or disclosed without the express written consent of Exactech, Inc Exactech, Inc EXACTECH Rev. A HyrdraLok Op. Tech *+$ *

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