Luminary ALIF. Disc preparation and implant insertion instruments.

Luminary ALIF. Disc preparation and implant insertion instruments. Technique Guide Instruments and implants approved by the AO Foundation

Table of Contents Introduction Luminary ALIF 2 AO Principles 4 Surgical Technique Preparation 5 Straight Anterior Approach 6 Anterolateral Approach (30º Offset) 16 Product Information Instruments 18 Set Lists 21 Image intensifier control Synthes Spine

Luminary ALIF Anterior Approach The Luminary ALIF instruments can be used in an anterior lumbar interbody fusion procedure using a straight anterior approach to the lumbar spine. The illustration depicts a Luminary CC-ALIF Spacer being implanted at the L5 S1 level. ALIF Synthes Quick Inserter/Distractor (SQUID) Provides distraction of disc space, insertion of implant and ejection of instrument in one simple procedure No assembly required Easy to use, integrated adjustable countersink, 3 mm and 6 mm depths from the outer wall of the implant to the outer wall of the vertebral body Shaft can be released for quick set-up and can be engaged for controlled insertion Spring ramps firmly hold implant during procedure Impact-free insertion 26 mm depth 30 mm width 2 Synthes Spine Luminary ALIF

Anterolateral Approach The Luminary ALIF instruments can also be used in an anterior lumbar interbody fusion procedure using an anterolateral approach, or 30 offset from straight anterior. This approach preserves the anterior longitudinal ligament and avoids patient vasculature. The illustration depicts a Luminary CC-ALIF Spacer being implanted at the L4 L5 level. 3 mm 6 mm Synthes Spine 3

AO Principles In 1958, the AO formulated four basic principles, 1 which have become the guidelines for internal fixation. They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active 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 Principles as Applied to the Spine 3 Anatomic 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, active 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, H. Willenegger: AO Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991. 2. Ibid. 3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin: Springer-Verlag. 1998. 4 Synthes Spine Luminary ALIF

mm Inches 24 mm GP1739-A 3/01 J3554 Preparation 1 Preoperative planning Determine surgical approach (anterior or anterolateral). The surgical approach, based on surgeon preference, determines the implant type. 2 Determine implant height Instrument 50 40 30 20 10 0 ANTERIOR HEIGHT 2 1 0 SYNTHES Spine 1690 Russell Road, Paoli, PA 19301 To order: 1-800-522-9069 ALIF SPACER PREOPERATIVE PLANNER Actual Size Lateral view 9 mm 11 mm 13 mm 15 mm 8052* ALIF Preoperative Planner ANTERIOR HEIGHT 17 mm 19 mm 21 mm 30 mm Preoperative planning is recommended for precise selection of a Luminary CC-ALIF spacer. Determine the implant height by comparing a lateral view on the ALIF preoperative planner with adjacent intervertebral discs on a lateral radiograph. 100 % actual size NOTE: All ALIF Spacers are 24 mm in anterior-posterior direction and 30 mm in lateral width. ALIF Preoperative Planner (8052) The implant must be firmly seated with a secure fit between the endplates when the segment is fully distracted. It is essential to use the tallest possible implant, as determined by the preoperative planning, to maximize segmental stability. Due to variations in radiographic magnification, the templates only provide an estimate of the ideal implant size. Templates represent 40% 80% (in 5% increments) and 100% actual size for use with MRI and CT scans. 10% and 15% magnification templates are available for x-ray use. * Also available Synthes Spine 5

Straight Anterior Approach Optional sets 01.605.600 ProPrep Disc Preparation Set 105.939 Anterior Instrument Set The ProPrep instrument set is a comprehensive collection of traditional disc preparation instruments to facilitate a complete discectomy. 01.605.600 1 Expose the disc Expose the midline of the intervertebral disc. 6 Synthes Spine Luminary ALIF

2 Perform discectomy Instrument 03.808.001 Scalpel Handle* Using a scalpel, cut a window in the annulus, centered on the vertebral midline to prepare the position for the implant. For the quickest and most effective removal of a disc, separate the disc from the endplate with an endplate elevator. Endplate elevators for ALIF surgery are available in the optional sets and individually through the Synthes catalog. *Note: Blades are not included in the set. Synthes Spine 7

Straight Anterior Approach continued 2 Perform discectomy continued Instruments 03.808.012 Disc Excisor Rongeur, 9 mm height 03.808.013 Disc Excisor Rongeur, 11 mm height 03.808.014 Disc Excisor Rongeur, 13 mm height Remove disc material from the intervertebral disc space using any combination of the following options: disc excisor rongeur, side-biting rongeur, or disc shaver/excisor. Note: Removing the superficial layers of the cartilaginous endplates exposes bleeding bone. Adequate preparation of the endplates is important to facilitate vascular supply to the bone graft. Excessive cleaning, however, may weaken the endplate due to removal of bone underlying the cartilaginous layers. Use the disc excisor rongeur to begin removing the disc. The disc excisor rongeurs are also effective to remove disc in the posterolateral disc space (Figure 1). Figure 1 8 Synthes Spine Luminary ALIF

Instruments 03.808.022 Bone Rongeur, side-biting, 9 mm height 03.808.023 Bone Rongeur, side-biting, 11 mm height 03.808.024 Bone Rongeur, side-biting, 13 mm height 03.808.032 ALIF Spreaders, 9 mm 21 mm 03.808.038 03.808.042 Disc Shavers/Excisors, 9 mm 21 mm 03.808.048 Use the side-biting rongeurs to remove disc material and cartilaginous tissue from the superior and inferior surfaces of the vertebral endplates. The double-sided cutting edges allow both surfaces to be cleaned simultaneously. Use the ALIF disc shavers/excisors for thorough removal of disc material and cartilaginous tissue from the intervertebral disc space. Multiple flutes maximize scraping and collection of disc material. The ALIF spreaders can be used to distract the disc space while allowing room to work contralaterally. The disc shavers/excisors can be used in a controlled manner to clean the lateral disc space. Synthes Spine 9

Straight Anterior Approach continued 3 Prepare endplates Instrument 03.808.101 ALIF Trial Spacer Rasp, with handle, 7 mm height After the discectomy is complete, use the double-sided rasp to remove the superficial cartilaginous layers of the endplates and expose bleeding bone. Note: Excessive removal of the subchondral bone may weaken the vertebral endplate. If the entire endplate is removed, subsidence and loss of segmental stability may result. 4 Determine implant size Instruments 03.808.102 ALIF Trial Spacer Rasps, quick release, 03.808.108 9 mm 21 mm 03.808.112 ALIF Trial Spacers, quick release, 03.808.118 9 mm 21 mm 394.951 Quick Release T-Handle The trial spacer rasps can be used to simultaneously trial the disc space for the implant while exposing bleeding bone. For final size determination, connect the appropriately sized trial spacer or trial spacer rasp to the desired length quick release T-handle. Insert the trial spacer into the intervertebral disc space using gentle impaction. Fluoroscopy can assist in confirming the fit and geometry of the trial spacer. 10 Synthes Spine Luminary ALIF

If the trial spacer appears too small or too tight, try the next larger or smaller size until the most secure fit is achieved. It is essential to use the tallest clinically reasonable implant to maximize segment stability. Optional instruments 03.808.003 Quick Release T-Handle, 185 mm PDL102 Slotted Mallet The slotted mallet can be used to facilitate the insertion or removal of the trial spacers and trial spacer rasps. Synthes Spine 11

Straight Anterior Approach continued 5 Insert implant T-handle Option 1: Using SQUID Instruments 03.808.121 ALIF Synthes Quick Inserter/Distractor (SQUID) Screw shaft 519.97* Autoclavable Oil Release the main thread by pushing the release button on the grip and slide the ejector fully back. Set the countersink depth 3 mm or 6 mm by turning the ejector in either direction with your fingers. The number closer to the tips of the instrument is the current setting. Note: Ejector can only be turned when in the keyhole. Engage/ release button SQUID Care Instructions To ensure maximum longevity of SQUID, complete these four steps after each use: Keyhole Ejector 1. Wash and disinfect instrument after surgery. 2. Apply autoclavable oil over entire length of the screw shaft. Spring ramp guides 3. Spread autoclavable oil over entire thread length by engaging the button and screwing the T-handle all the way down and back. 4. Sterilize SQUID before use (see package insert). Pusher Tips *Also available 12 Synthes Spine Luminary ALIF

Once the countersink depth is set, place the instrument flat on the table to load the implant. Pack bone graft material into the center of the implant as appropriate. Place the implant onto the bottom spring ramp. Holding both sides of the implant, engage the grooves with the spring ramp guides and gently slide the implant forward until the implant is held without sliding back. Note: The tips of the inserter will be inserted into the disc space up to the depth stops on the spring ramps; to allow full insertion, the tips must not be spread apart. Slide the pusher up to the implant and engage the main thread by pressing the engage button. The implant is now held securely. Depth stops Main thread Synthes Spine 13

Straight Anterior Approach continued 5 Insert implant continued Option 1: Using SQUID continued Place the tips of the instrument into the disc space so the depth stops on the spring ramps touch the anterior rim of the vertebral body. The tips of the instrument are 26 mm deep and 30 mm wide. Note: It is important to remember that the pusher will be moving toward the vertebral body and the ejector is proud above the spring ramps and stops. Be aware of soft tissue and blood vessels that may be in the path of the pusher and ejector as they move toward and push against the vertebral bodies. With the main thread engaged, turn the T-handle on the SQUID to advance the implant down the spring ramps and into the disc space. The force required to turn the T-handle will increase as the implant advances down the spring ramps and the instrument distracts the disc space. Continue turning the T-handle until the instrument is fully ejected and released. An audible click as the spring ramps spring back to meet each other confirms that the implant is seated and the instrument is fully ejected and released. 14 Synthes Spine Luminary ALIF

Option 2: Using implant holder and impactor Instruments 03.808.122 ALIF Implant Holder 03.808.123 ALIF Impactor, crescent Insert the implant using the ALIF implant holder, ensuring that the tallest side of the implant lies against the holder. The implant holder aligns with the preformed grooves or slot on the implant for easy insertion. Ensure that the implant is held flush against the holder. Tighten the locking screw on the implant holder to firmly secure the instrument jaws against the implant. Introduce the spacer into the intervertebral disc space until the implant is flush or slightly recessed. Slight impaction on the implant holder may be necessary. Release the implant holder by loosening the locking screw and use the impactor to fully seat the implant. Important: Before use, ensure that the impactor fits flush against the implant. Do not forcibly strike the impactor when tapping the implant into position. Synthes Spine 15

Anterolateral Approach (30 Offset) 1 Expose and remove disc and prepare endplate For anterolateral insertion, the center of the implant will sit 30 offset to the anterior vertebral midline. Remove the disc and prepare the endplates according to Steps 2 and 3 of the straight anterior approach (pages 7 10). 2 Distract and size Instruments 03.808.101 ALIF Trial Spacer Rasp with handle, 7 mm 03.808.102 ALIF Trial Spacer Rasps, quick release, 03.808.108 9 mm 21 mm 03.808.112 ALIF Trial Spacers, quick release, 03.808.118 9 mm 21 mm Determine the correct implant size using the ALIF trial spacers or trial spacer rasps. The same trial spacers and trial spacer rasps can be used for anterior or anterolateral approaches. The desired approach can be changed by unscrewing the sleeve, aligning the head in the correct position and reattaching the sleeve. Insert the trial spacer and determine the correct implant size as described in Step 4 of the anterior approach (page 10). 16 Synthes Spine Luminary ALIF

3 Insert the implant Insert the implant according to Step 5 of the straight anterior approach (pages 12 15). Synthes Spine 17

Instruments 03.808.001 Scalpel Handle 03.808.003 Quick Release T-Handle, 185 mm 03.808.012 Disc Excisor Rongeurs, 9 mm 13 mm height 03.808.014 03.808.022 Bone Rongeurs, side-biting, 03.808.024 9 mm 13 mm height 03.808.032 ALIF Spreaders, 9 mm 21 mm height 03.808.038 18 Synthes Spine Luminary ALIF

03.808.042 Disc Shavers/Excisors, 9 mm 21 mm height 03.808.048 03.808.101 ALIF Trial Spacer Rasp, with handle, 7 mm height 03.808.102 ALIF Trial Spacer Rasps, quick 03.808.108 release, 9 mm 21 mm height 03.808.112 ALIF Trial Spacers, quick release, 03.808.118 9 mm 21 mm height 03.808.121 ALIF Synthes Quick Inserter/Distractor (SQUID) Synthes Spine 19

Instruments continued 03.808.122 ALIF Implant Holder, with grooves 03.808.123 ALIF Impactor, crescent 394.951 Quick Release T-Handle PDL102 Slotted Mallet 20 Synthes Spine Luminary ALIF

Luminary ALIF Disc Preparation Instrument Set (01.808.003) Graphic Case 60.808.000 Graphic Case, for Luminary ALIF Disc Preparation Instrument Set Instruments 03.808.001 Scalpel Handle* 03.808.003 Quick Release T-Handle, 185 mm 394.951 Quick Release T-Handle, 2 ea. Disc Excisor Rongeurs 03.808.012 9 mm height 03.808.013 11 mm height 03.808.014 13 mm height Bone Rongeurs, side-biting 03.808.022 9 mm height 03.808.023 11 mm height 03.808.024 13 mm height ALIF Spreaders 03.808.032 9 mm height 03.808.033 11 mm height 03.808.034 13 mm height 03.808.035 15 mm height 03.808.036 17 mm height 03.808.037 19 mm height 03.808.038 21 mm height Disc Shavers/Excisors 03.808.042 9 mm height 03.808.043 11 mm height 03.808.044 13 mm height 03.808.045 15 mm height 03.808.046 17 mm height 03.808.047 19 mm height 03.808.048 21 mm height * Blades not included Note: For additional information, please refer to package insert. Synthes Spine 21

Luminary ALIF Insertion Instrument Set (01.808.103) Graphic Case 60.808.002 Graphic Case for Luminary ALIF Insertion Instrument Set Instruments 03.808.003 Quick Release T-handle, 185 mm 03.808.101 ALIF Trial Spacer Rasp, with handle, 7 mm height 03.808.121 ALIF Synthes Quick Inserter/Distractor (SQUID) 03.808.122 ALIF Implant Holder, with grooves 03.808.123 ALIF Impactor, crescent 394.951 Quick Release T-handle, 2 ea. PDL102 Slotted Mallet ALIF Trial Spacer Rasps, quick release 03.808.102 9 mm height 03.808.103 11 mm height 03.808.104 13 mm height 03.808.105 15 mm height 03.808.106 17 mm height 03.808.107 19 mm height 03.808.108 21 mm height ALIF Trial Spacers, quick release 03.808.112 9 mm height 03.808.113 11 mm height 03.808.114 13 mm height 03.808.115 15 mm height 03.808.116 17 mm height 03.808.117 19 mm height 03.808.118 21 mm height 22 Synthes Spine Luminary ALIF

Also Available Optional Sets 01.605.600 ProPrep Disc Preparation Set 105.939 Anterior Instrument Set Instruments Disc Excisor Rongeurs 03.808.011 7 mm height 03.808.015 15 mm height 03.808.016 17 mm height 03.808.017 19 mm height 03.808.018 21 mm height Bone Rongeurs, side-biting 03.808.025 15 mm height 03.808.026 17 mm height 03.808.027 19 mm height 03.808.028 21 mm height 8052 ALIF Preoperative Planner Synthes Spine 23

Synthes Spine 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com 2006 Synthes, Inc. or its affiliates. All rights reserved. ProPrep and Synthes are trademarks of Synthes, Inc or its affiliates. Printed in U.S.A. 8/08 J6782-B