Instruments and implants for stand-alone anterior lumbar interbody fusion (ALIF) Surgical Technique ssssr DePuy Synthes PART OF THE |oktOH4|okH»l FAMILY OF COMPANIES

Image intensifier control This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance For general information about reprocessing, care and maintenance of Synthes reusable...

Introduction SynFix-LR System 2 Surgical Technique Preoperative Planning 8 Selection and Packing of Implant 15 Implant Insertion Option A: SQUID 18 Option B: Implant Holder 21 Screw Insertion Option A: Standard Instruments 23 Option B: Mini-Open Instruments 31 Product Information Implant Removal 38 SynFix-LR Trial Implants 42 SynFix-LR Aiming Devices 46 Additional Recommended Sets 50 SynFix-LR System Surgical Technique DePuy Synthes 1

SynFix-LR System. Instruments and implants for stand-alone anterior lumbar interbody fusion (ALIF). SynFix-LR Implants The SynFix-LR implant is a stand-alone ALIF device that incorporates the benefits of an anterior fixation plate and a radiolucent interbody spacer. The design creates a zero profile construct and includes four locking screws that is designed to provide anterior fixation and stability. Stand-alone ALIF • Biomechanically equivalent to a spacer with pedicle screws.¹* • PEEK spacer is designed to provide modulus of elasticity similar to cortical bone. • Titanium plate with locking...

Anatomic shape • The SynFix-LR is convex to match the anatomy of the disc space. • Two footprints and two angles are offered to accommodate individual patient anatomy. Screw and plate fixation • One-step conical locking mechanism is designed to ensure screws securely lock to plate and eliminates the need for a blocking plate. • Locking screws is designed to provide stability and load transfer near the cortex of the vertebral body. • Four locking screws diverge to form a fixed-angle construct that creates a wedge of bone (highlighted in yellow) for fixation. • Self-tapping cortical threads allow...

SynFix-LR System. Instruments and implants for stand-alone anterior lumbar interbody fusion (ALIF). Instruments for insertion of the implant Option A: Quick inserter (SQUID) The SynFix SQUID inserts in one simple step, without impaction. Implant holder and distractor For the insertion of the implant while distraction is maintained. 4    DePuy Synthes  SynFix-LR System  Surgical Te

Instruments for insertion of the screws Standard instruments option A: Mini-open instruments option B: Awl with cardan joint Penetrates the cortical rim for subsequent screw insertion. Aiming device mini-open with fixed handle Designed for precise positioning of the locking screws. Tweezers For guiding awl and screwdriver into the aiming device. Awl for SynFix-LR mini-open Penetrates the cortical rim for subsequent screw insertion. Aiming device holder with implant coupling For insertion of the aiming device. Easily removable to facilitate access for screw insertion. Aiming device Designed for...

The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability – Alignment – Biology – Function.1,2 Stability Stabilization to achieve a specific therapeutic outcome sagittal axial Biology Etiology, pathogenesis, neural protection, and tissue healing Function Preservations and restoration of function to prevent disability DePuy Synthes SynFix-LR System Alignment Balancing the spine in three dimensions

Indications Lumbar and lumbosacral pathologies which may require anterior segmental arthrodesis, including: • Localised symptomatic degenerative disc disease • Revision surgery for failed decompression syndrome • Pseudoarthrosis Contraindications • Spinal fractures • Spinal tumor • Osteoporosis • Infection Contraindications for stand-alone application • Spondylolisthesis • Severe segmental instability SynFix-LR System  Surgical Technique 

Preoperative Planning 1. Preoperative planning Instruments X000045 X-ray Template for SynFix-LR, 26 × 32 mm, 8° X-ray Template for SynFix-LR, 26 × 32 mm, 12° X-ray Template for SynFix-LR, 30 × 38 mm, 8° X-ray Template for SynFix-LR, 30 × 38 mm, 12° Determine the approximate implant size by comparing the SynFix-LR X-ray template with a lateral radiograph of the patient’s adjacent intervertebral discs. Notes: • The height indicated on the template is approximately 1 mm lower than that of the actual spacer to account for pene ration of the teeth into the vertet bral endplate. • It is recommended...

1. Patient positioning For an anterior approach to the lower lumbar levels, p osition the patient in a slight Trendelenburg position. 2. Anterior access and approach Recommended set 01.609.102 SynFrame Basic System in Vario Case The surgical approach depends on the level to be treated. Locate the correct operative disc level and incision location by taking a lateral fluoroscopic view while holding a straight metal instrument at the side of the patient. This ensures that the incision and exposure will allow direct visualization into the disc space. Expose the operative disc level through a standard...

3. Exposure The locking head screws of the SynFix-LR must be inserted from a direct anterior approach. Expose the intervertebral disc such that there is sufficient space on either side of the vertebral midline, equal to half the width of the SynFix-LR. This enables the insertion of the implant without interference from adjacent soft tissue structures (major vessels, peri oneum etc.). t Once the spacer has been inserted, visualization of the entire anterior fixation plate is necessary for insertion of the locking head screws. 11    DePuy Synthes  SynFix-LR System  Surgical T