Surgical Technique. TraXis. Precision. Transforaminal Lumbar Interbody Fusion Spacer. The Art & Science of Spine Surgery

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1 Surgical Technique Precision TraXis Transforaminal Lumbar Interbody Fusion Spacer The Art & Science of Spine Surgery

3 Table of Contents Introduction 3 Indications 4 Key Instruments 5 Surgical Technique 7 Kit Contents 15 Implant and instrumentation designed for MIS approach Available in PEEK-OPTIMA 1 and titanium alloy

4 Introduction MIS capability. Precise results. Minimally Invasive Surgery (MIS) represents one of the most exciting and dynamic segments of spine surgery. At Abbott Spine we are committed to advancing the art and science of spine surgery, and our goal is to make minimally invasive techniques simple and intuitive. We are determined to meet the demands of spine surgeons by offering a complete MIS solution, one that combines the capabilities of an open technique with the benefits of a minimalist approach. Ideal for use with Abbott Spine s MIS Pedicle Screw System, PathFinder, TraXis crescent shape and articulating instruments facilitate precise implant placement, even through the smallest working space. TraXis is the preferred interbody spacer for the surgeon who demands the benefits of a Transforaminal approach: Exceptional visualization and control TraXis low-profile Inserter provides a clear viewing channel when working through a Harmony Port or Retractor system Ease of placement Uniquely designed implant teeth to enable arcing trajectory across midline Large capacity for graft placement Open structure provides large capacity for AlloFuse or other graft material Compatible with Harmony posterior discectomy instrumentation 3

Indications Indications TraXis is a transforaminal interbody fusion device that is intended for use in the thoracic and/or thoracolumbar spine (T3-S1) to restore the disc height after discectomy

5 Indications Indications TraXis is a transforaminal interbody fusion device that is intended for use in the thoracic and/or thoracolumbar spine (T3-S1) to restore the disc height after discectomy procedures and to regain biomachnical stability and balance of the spine, as well as to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). TraXis is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. TraXis is intended to be used with bone graft. Contraindications Disease conditions which have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other posterior spinal instrumentation system. Any entity or condition that totally precludes the possibility of fusion, i.e. cancer, kidney dialysis or osteopenia, is a relative contraindication. Other relative contraindications include obesity, pregnancy, certain degenerative disease, and foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant. Known patient sensitivity to device materials (PEEK-OPTIMA). When used without posterior fixation, the device should only be used for Grade 1 or less spondylolisthesis or retrolisthesis. 4

Key Instruments Harmony Posterior Curettes Prepare vertebral body endplates and remove disc material. Feature bayoneted shaft and reduced glare finish.

6 Key Instruments Harmony Posterior Curettes Prepare vertebral body endplates and remove disc material. Feature bayoneted shaft and reduced glare finish. Curettes available: Straight, Right, Left, Up-biting, Down-biting, Ring and O Brien. Distractors Incrementally distract disc space, shave endplates. Cutting, Smooth Distractors available in 6 15 mm sizes. Rongeurs Cut bony structures, remove disc material. Kerrison, Pituitary Rongeurs, with bayoneted shaft and reduced glare finish, available in 2 4 mm sizes. 5

7 Key Instruments TraXis Trials and Rasps Identify appropriate implant size, create pathway for implant placement. Fixed and modular versions available. Modular tools give surgeon flexibility to determine correct tip angle. Inserter Mates with implant channels, providing maximum control with minimal Inserter profile. Tamp Advances implant into final position. Fixed and modular versions available. Modular tamp gives flexibility to determine correct tamp angle. 6

8 Surgical Technique Figure 1 Figure 2 Figure 3 Patient Positioning Position on radiolucent table with adequate clearance for a fluoroscopic C-arm (for A/P, lateral and oblique images of pedicle and vertebral body). All other hardware utilized for patient positioning should be checked for radiolucency. Targeting Pedicle Obtain A/P, lateral images of affected level. Begin Harmony Port placement, accessing facet with Targeting Needle and K-wire. Sequential Dilation Sequentially slide Dilators #1 6 over K-wire; slide matching Depth Gauge over largest dilator, flange positioned distally. 7 Depth Gauges may be used as pushers to advance dilators through musculature.

end of Dilator #6 in Depth Gauge window.

facet. Adjust angle by wanding dilators.

9 Figure 4 Figure 5 Port Measurement Rest flange against skin, locating proximal end of Dilator #6 in Depth Gauge window. Identify necessary port length, referencing measurements on side of Depth Gauge and rounding up. Port Placement Remove port from sterile package, slide over dilator and dock on facet. Adjust angle by wanding dilators. Attach port to Snake Arm or Surgical Assist Mechanism (SAM) Arm. 8

10 Figure 6 Figure 7 Bony Decompression Using osteotomes and Kerrison Rongeurs, remove facet and portions of lamina. Ligamentum Flavum Cut ligamentum flavum from inferior portion of lamina. Mobilize with Woodson or fine curettes. Control epidural bleeding with bipolar cautery, avoiding contact with port or other instruments. 9

Annular Window Remove blood, small tissue

11 Figure 8 Figure 9 Nerve Root, Dura Mobilization Free nerve root and dura from soft tissue; probe bony structures with Ball Probe. Retract nerve root and dura. Annular Window Remove blood, small tissue fragments with suction catheter; create annular window with Annulus Knife. 10

12 Figure 10 Figure 11 Remove Disc Tissue Insert cutting distractors into disc rotating to free disc tissue. Remove disc fragments with pituitary rongeurs. Endplate Preparation With osteomes, remove osteophytes and posterior lip of adjacent vertebral bodies. Remove remaining endplate cartilage with curettes. 11

Figure 12 Figure 13 Figure 13a Distraction and Sizing With progressively sized distractors, open space to desired height. Connect distractor to Comfort T-Handle.

With Rasp locked straight, advance into disc space. Countersink, loosen locking knob, angle rod medially and relock rasp at desired angle.

13 Figure 12 Figure 13 Figure 13a Distraction and Sizing With progressively sized distractors, open space to desired height. Connect distractor to Comfort T-Handle. Insert into space, handle parallel to vertebral endplate. Rotate axis, opening space to a height equal to distractor. Channel Preparation, Modular Rasp Option Connect Modular rasp to Trial Rod. With Rasp locked straight, advance into disc space. Countersink, loosen locking knob, angle rod medially and relock rasp at desired angle. Draw rod laterally and impact in arcing trajectory, advancing rasp medially until it has traversed midline. Fully loosen locking knob, allowing rasp to freely rotate during extraction. Channel Preparation, Fixed Rasp Option Insert rasp into disc space in arcing trajectory until across midline. T-Handle may be attached to Fixed Rasp stem for improved control. 12

14 Figure 14 Figure 14b Final Implant Sizing, Modular Trial Option Connect desired trial to Trial Rod. Position across midline, adjusting tip with Trial Rod as described in Channel Preparation, Modular Rasp Option. Confirm final position radiographically. Final Implant Sizing, Fixed Trial Option Position trial across midline. T-Handle may be attached to Fixed Trial stem for additional control. Confirm final position radiographically. 13

Figure 15 Figure 16 Final Implant Preparation Select implant size based on trial fit. With Bone Funnel/Bone Tamp, fill implant with AlloFuse or other graft material.

15 Figure 15 Figure 16 Final Implant Preparation Select implant size based on trial fit. With Bone Funnel/Bone Tamp, fill implant with AlloFuse or other graft material. Connect to Inserter, mating grips to implant s proximal channels. Implant Insertion Introduce implant into disc space, carefully advancing into previously created channel. Countersink 1 2 mm from posterior edge of vertebral body. Confirm position radiographically and detach implant from Inserter. 14

16 Figure 17 Figure 17a Final Positioning, Modular Tamp Option Connect tip of Modular Tamp to Trial Rod. With tamp tip in straight position, mate it to implant and tap with mallet to advance anteriorly, following channel created by rasp. Final Positioning, Fixed Tamp Option Mate Fixed Tamp to implant and tap with mallet to advance anteriorly, following channel created by rasp. To reposition tip, remove from disc space and turn, locking knob to reposition. Maintain final position while extracting rod. 15

Figure 18 Figure 18a Figure 19 Position Confirmation Confirm position

If using TraXis Vue, refer to tantalum marker beads to confirm orientation.

Implant Compression Insert rods into pedicle screw construct, completing

17 Figure 18 Figure 18a Figure 19 Position Confirmation Confirm position radiographically. If using TraXis Vue, refer to tantalum marker beads to confirm orientation. Beads should appear on lateral (Fig. 18) and A/P (Fig. 18a). Implant Compression Insert rods into pedicle screw construct, completing assembly. Using compressor from pedicle screw system kit, apply load to TraXis implant and lock construct. Additional bone graft may be packed into space around implant. 16

18 Kit Contents 17 Harmony Posterior Kit Part Number Description Standard Quantity Comfort T-Handle Cutting Distractor - 6mm Cutting Distractor - 7mm Cutting Distractor - 8mm Cutting Distractor - 9mm Cutting Distractor - 10mm Cutting Distractor - 11mm Cutting Distractor - 12mm Cutting Distractor - 13mm Cutting Distractor - 14mm Cutting Distractor - 15mm Smooth Distractor - 6mm Smooth Distractor - 7mm Smooth Distractor - 8mm Smooth Distractor - 9mm Smooth Distractor - 10mm Smooth Distractor - 11mm Smooth Distractor - 12mm Smooth Distractor - 13mm Smooth Distractor - 14mm Smooth Distractor - 15mm Kerrison Rongeur - 2mm Forward Kerrison Rongeur - 3mm Forward Kerrison Rongeur - 4mm Forward Kerrison Rongeur - 3mm Straight Pituitary Rongeur - 2mm Straight Pituitary Rongeur - 3mm Straight Pituitary Rongeur - 4mm Straight Pituitary Rongeur - 2mm Up Pituitary Rongeur - 3mm Up Pituitary Rongeur - 4mm Up 1 Sellables Part Number Description Standard Quantity Large Curette, Up Large Curette, Straight Large Curette, Left Large Curette, Right O Brien Curette Ring Curette Down Biting Curette - Right Down Biting Curette - Left Small Curette, Down Small Curette, Down Reverse Small Curette, Straight Small Curette, Forward Small Curette, Left Small Curette, Right Osteotome, Straight Osteotome, Curved Osteotome, Angled Penfield Dissector Woodson Elevator Nerve Hook Ball Probe Nerve Root Retractor - Full Angle, 5mm Nerve Root Retractor - Full Angle, 9mm Nerve Root Retractor - Bayonet, 5mm Nerve Root Retractor - Bayonet, 9mm Annulus Knife Handle Retractor with Suction - 12F Bipolar Forceps 1

19 TraXis Modular Kit Part Number Description Standard Quantity Inserter Inserter/Extractor Trial Rod T-Handle Slaphammer Fixed Tamp Tamp Tip Bone Funnel Bone Tamp Fixed Rasp - 7mm Modular Rasp - 9mm Modular Rasp - 11mm Modular Rasp - 13mm Modular Rasp - 15mm Fixed Trial- 7mm Modular Trial - 9x9x21mm Modular Trial - 9x9x25mm Modular Trial - 11x9x21mm Modular Trial - 11x9x25mm Modular Trial - 11x11x Modular Trial - 11x11x Modular Trial - 13x11x Modular Trial - 13x11x Modular Trial - 15x11x Modular Trial - 15x11x25 1 TraXis Fixed Kit Part Number Description Standard Quantity Inserter Inserter/Extractor T-Handle Slaphammer Fixed Tamp Bone Funnel Bone Tamp Fixed Rasp - 7mm Fixed Rasp - 9mm Fixed Rasp - 11mm Fixed Rasp - 13mm Fixed Rasp - 15mm Fixed Trial - 7mm Fixed Trial - 9mm Fixed Trial - 11mm Fixed Trial - 13mm Fixed Trial - 15mm 1 18

20 Our Vision Founded in 1996, Abbott Spine was built on a foundation of innovation. For inspiration, we have listened to surgeons, studied surgical indications, techniques and biomechanics. We have discovered innovations that deliver simplicity to the operating suite and successful clinical outcomes to patients. In addition to the enhancement of our core line of spinal fusion products, Abbott Spine is strategically focused on the establishment of a more diverse field of solutions for surgeons and patients. In collaboration with surgeon partners, we are dedicated to the exploration of the art and science of spine surgery, developing therapies that are less invasive and intervene earlier in the continuum of care, as well as providing improvements for both physicians and their patients. Abbott Spine Cité Mondiale 23, parvis des Chartrons Bordeaux - France Tel. 33 (0) Fax 33 (0) AS ICE-V1-May 2006

TraXis TLIF Interbody System

TraXis TLIF Interbody System Surgical Technique Solutions by the people of Zimmer Spine. zimmerspine.com A TLIF that s ahead of the curve. From the people of Zimmer Spine. Minimally Invasive Surgery (MIS)