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SYNFIX Evolution Secured Spacer System Surgical Technique Depuy Synthes 1 SYNFIX® EVOLUTION

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SYNFIX Evolution Secured Spacer System Surgical Technique Depuy Synthes 1 SYNFIX® EVOLUTION SYNFIX® EVOLUTION SECURED SPACER SYSTEM Instruments and implants for stand-alone anterior lumbar interbody fusion Instruments and implants approved by the AO Foundation. This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE Image intensifier control This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended. Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, 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 devices, instrument trays and cases, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance TABLE OF CONTENTS INTRODUCTION SYNFIX Evolution 2 Implants 2 Instruments 4 SQUID Inserter/Distractor Option 5 Background of SYNFIX Evolution Implant 6 SYNFIX Evolution System Benefits 7 AO Spine Principles 9 Indications and Contraindications 10 SURGICAL TECHNIQUE Preparation 11 Access and Exposure 12 Discectomy 13 Distraction and Segment Mobilization 15 Trialing 16 Implant Preparation 21 Implant Insertion 23 Option A: Using Aiming Device 25 Option B: Using Squid® Inserter/Distractor 29 Screw Insertion 37 Screw Removal 49 Cage Removal 53 PRODUCT INFORMATION Disassembly and Assembly Instructions 57 Maintenance U-Joint Instruments 64 Implants 65 Instruments 73 BIBLIOGRAPHY 84 SYNFIX Evolution Secured Spacer System Surgical Technique DePuy Synthes 1 SYNFIX® EVOLUTION IMPLANTS Fine and Blunt Tip Fine tip screw option for sclerotic bone Double Lead Screw Self-tapping double lead Graft Retention Ridge titanium alloy screw for Enhances graft retention rapid insertion Integrated Titanium Plate with Locking Screws Zero profile plate design with angular stable lock- ing screws Keyed Connection Secures implant to instru- ment interface for intuitive connection and positive tactile feedback Anatomic Convexity* Lordotic Angulation Distinct cranial and caudal 4 angulations 6°-10°-14°- convexities accommodate 18° support sagittal align- variances in endplate anat- ment restoration omies * except for symmetric 6° implant 2 DePuy Synthes Surgical Technique SYNFIX Evolution Secured Spacer System Large Graft Lumen To maximize graft volume PEEK Cage Facilitates radiographic assessment of fusion Bullet Nose Implant Heights Allows for ease of Expanded range of implant insertion heights from 10.5 mm to 19.0 mm support individual patient anatomy SQUID® Inserter Rails Interface for Evolution SQUID™ Inserter/Distrac- tor option Radiographic Marker Deep Footprint Option Tantalum x-ray marker Deeper footprint option indicates the actual provides 3 mm additional posterior edge of the depth in the AP direction implant to accommodate varied anatomies SYNFIX Evolution Secured Spacer System Surgical Technique DePuy Synthes 1 SYNFIX® Evolution INSTRUMENTS Ratchet Torque Limiting Handle Single Instrument Ratchet for enhanced ergonomics for Implant Insertion during screw insertion, combined Reduces number of with torque limiting function for instrument passes fi nal tightening. Detachable Holder Removable implant holder allows for increased visibil- ity during screw insertion Soft Tissue Retractor Protects and retracts soft tissue Thread Lock Sleeve Locks screw to screwdriver and disengages automati- cally when inserting screw through the aiming device Aiming Device* Protection Sleeve 4-hole aiming device Separates soft tissue from allows for insertion of the rotating U-joint to all screws without an prevent soft tissue uptake additional rotation step * except for SYNFIX Evolution Aiming Device 17 mm and 19 mm 1 DePuy Synthes Surgical Technique SYNFIX Evolution Secured Spacer System SQUID® INSERTER/DISTRACTOR OPTION Controlled Distraction Distracts and inserts in one simple step, without impaction Positioning Options Allows positioning of the implant from 0 mm to + 6 mm proud to the ante- rior aspect of the vertebral body Rails Provide guidance during implant insertion Thin Blades Reduce risk of over distraction during implant insertion SYNFIX Evolution Secured Spacer System Surgical Technique DePuy Synthes 1 BACKGROUND OF SYNFIX EVOLUTION IMPLANT The SYNFIX® Evolution Implant, a stand-alone anterior lumbar interbody fusion (ALIF) implant, employs the 1 SYNFIX Implant technology which has been used clini- cally in the SYNFIX® LR Implant since 2004. The SYNFIX Implant technology is a zero-profile construct that includes four diverging locking screws. This design negates, in most circumstances, the need for additional fixation. Biomechanical stability 2 The SYNFIX LR Implant is equivalent to a cage with Biomechanical Stability Comparison1 9 pedicle screws in flexion, extension, lateral bending and Intact 1 superior in axial rotation (2). The superior stability of the 8 SYNFIX LR Implant SYNFIX LR Implant is shown compared to other stand- 7 360° Fusion alone ALIF implants.2,3# 6 Biomechanical stability is delivered through: 5 • An integrated titanium plate with four diverging 4 locking screws that form a fixed-angle construct. This creates a wedge of bone designed as an anchor 3 to potentially prevent fixation failure (1). 2 Range Motion of (°) • A non-rigid connection between locking plate and 1 PEEK cage allowing for load sharing2 0 • PEEK cage with elastic modulus similar to cortical bone Flexion* Extension* Lateral Axial (6 Nm) (6 Nm) Bending* Rotation** • Self-tapping cortical threads (6 Nm) (6 Nm) Clinical experience * SYNFIX LR Implant is statistically equivalent to 360° fusion ** SYNFIX LR Implant is statistically superior in axial rotation to a spacer The SYNFIX LR Implant has been shown to be as with pedicle screws effective as 360° fusion in achieving fusion in the man- agement of discogenic back pain over one and two levels.4,5 1 Cain et al (2005) 2 Schleicher et al (2008) 3 Freeman et al (2016) 4 Ardern et al (2008) 5 Siepe et al (2015) # Biomechanical test results may not necessarily be indicative of clinical performance. 6 DePuy Synthes Surgical Technique SYNFIX Evolution Secured Spacer System SYNFIX EVOLUTION SYSTEM BENEFITS Biomechanical stability The SYNFIX Evolution Implant has been designed to 1 preserve the biomechanical stability of the SYNFIX LR Implant by delivering: • An integrated titanium plate with four diverging locking screws that form a fi xed-angle construct. This creates a wedge of bone designed as an anchor to potentially prevent fi xation failure (1). • A non-rigid connection between locking plate and PEEK cage allowing for load sharing2 • PEEK cage with elastic modulus similar to cortical bone • Self-tapping cortical threads 2 Comprehensive implant portfolio S SD 126 implants to support an optimal fi t and fi ll of disc space and restoration of sagittal alignment (2): • 6 footprints • 6 heights • 4 angles M MD L LD Height Angle Anatomic convexity of the cage design. Greater superior 3 convexity for optimal fi t to lumbar and lumbosacral end- R1 plates (3). R2 R2 > R1* *except for symmetric 6° implant SYNFIX Evolution Secured Spacer System Surgical Technique DePuy Synthes 1 Synfi x Evolution System Benefi ts Optimized lumen design to maximize graft volume (1) 1 Designed to increase procedural efficiencies • Double lead screw thread for rapid screw insertion (2) 2 • Protection sleeve avoids soft tissue wrap-up in 3 U-joint (3a) a • Thread lock sleeve locks screw to screwdriver and disengages automatically when inserting screw through the aiming device (3b) b • Reduced number of instrumentation steps: 4 5 One instrument for cage and screw insertion (4) Bullet nose of the PEEK cage allows for ease of insertion (5) 1 DePuy Synthes Surgical Technique SYNFIX Evolution Secured Spacer System AO SPINE PRINCIPLES 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 sagittal Alignment Stabilization to achieve Balancing the spine in axial a specifi c therapeutic out- coronal three dimensions come Biology Function Etiology, pathogenesis, Preservations and restora- neural protection, tion of function to prevent and tissue healing disability Copyright © 2012 by AOSpine 1 Aebi et al (1998) 2 Aebi et al (2007) SYNFIX Evolution Secured Spacer System Surgical Technique DePuy Synthes 1 INDICATIONS AND CONTRAINDICATIONS Intended Use SYNFIX Evolution Secured Spacer System is an implant and instrument system for stand-alone anterior lumbar interbody fusion (ALIF) for skeletally mature patients. It is intended to replace lumbar interbody discs and to fuse adjacent vertebral bodies at vertebral levels L1-S1 follow- ing anterior lumbar discectomy for stabilization of the lumbar spine. Indications Lumbar and lumbosacral pathologies which may require anterior segmental arthrodesis, including: • Localized 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 11 DePuy Synthes Surgical Technique SYNFIX Evolution Secured Spacer System PREPARATION Required Sets 01.835.004 SYNFIX Evolution Set, Complete Optional Anterior Instrument Sets 01.600.100
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