TraXis TLIF Interbody System

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1 TraXis TLIF Interbody System Surgical Technique Solutions by the people of Zimmer Spine. zimmerspine.com

2 A TLIF that s ahead of the curve. From the people of Zimmer Spine. Minimally Invasive Surgery (MIS) represents one of the most exciting and dynamic segments of spine surgery. At Zimmer Spine, we are committed to developing minimally invasive techniques that are 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 the PathFinder MIS Pedicle Screw System, the TraXis implant s crescent shape and articulating instruments facilitate precise placement, even through the smallest working space. A preferred TLIF for the surgeon who demands the benefits of a transforaminal approach, brought to you by the people of Zimmer Spine.

3 Table of Contents Indications/Contraindications 1 TraXis Implants 3 Harmony Posterior Instruments 4 TraXis Instruments 5 Surgical Technique 8 Kit Contents 19 Warnings and Precautions 25

4 Indications/Contraindications Indications The intended purpose of the TraXis system is that it be used for interbody fusion and/or resection or excision of the vertebral bodies of the thoracolumbar spine. TraXis is indicated for the treatment of degenerative disc disease, disc herniation, foraminal stenosis, tumor, trauma, deformity (including scoliosis, spondylolisthesis and retrolisthesis) and failed previous fusion. TraXis was designed to be placed through a posterior incision. 1

5 Contraindications 1. 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. 2. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. 3. 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. Severe osteoporosis may increase the risk of postoperative loss of disc height. 4. 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. 5. When used without posterior fixation, the device should only be used for Grade 1 or less spondylolisthesis or retrolisthesis. 2

Ti Vue Length 9mm Width Implant 7mm* 21mm X 25mm X Height 9mm X X 11mm X X Length 11mm

6 TraXis Implants With a crescent shape that s ideal for a transforaminal approach, this innovative device facilitates precise implant placement even through minimalist access. Ti Vue Length 9mm Width Implant 7mm* 21mm X 25mm X Height 9mm X X 11mm X X Length 11mm Width Implant 11mm 21mm X 25mm X Height 13mm X X 15mm X X *Available in Vue (PEEK-OPTIMA) only. 3

7 Harmony Posterior Instruments Smooth Distractors (6-15mm) Cutting Distractors (6-15mm) Incrementally distract the disc space. Incrementally distract the disc space and shave vertebral endplates. Kerrison Rongeurs (2-4mm) Pituitary Rongeurs (2-4mm) Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish. Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish. 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. 4

8 TraXis Instruments Fixed Instrumentation Fixed Trial (7 15mm) Fixed Rasp (7 15mm) Identifies appropriate implant size via fixed instrumentation in varied heights. Creates a pathway for implant placement via fixed instrumentation in varied heights. Fixed Tamp Advances the implant into its final position. 5

Identifies appropriate implant size via modular instrumentation in a full variety of sizes that match the implant.

9 Modular Instrumentation Trial Rod Modular Trial (9 15mm) Attaches to Modular Trials, Rasps and Tamp Tip for flexible angled instrumentation. Identifies appropriate implant size via modular instrumentation in a full variety of sizes that match the implant. Modular Rasp (9 15mm)) Modular Tamp Tip Creates a pathway for implant placement via modular instrumentation. Provides flexibility to determine the correct Tamp angle to advance the implant into final position. 6

10 Additional Instrumentation Inserter/Extractor Slaphammer Mates with implant channels, providing maximum control with minimal profile for implant placement and/or removal. Provides additional force for removal of instrumentation, if needed. Bone Funnel Bone Tamp Used to pack autograft material into disc space or implant. 7

All other hardware utilized for patient positioning should be checked for radiolucency.

11 Surgical Technique Preparation and Access Step 1 Patient Positioning Position the patient on a 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. Step 2 Pedicle Targeting Obtain A/P and lateral images of the affected level. Begin Harmony Port placement, accessing the facet with the Targeting Needle and K-wire. 8

Step 3 Sequential Dilation Sequentially slide Dilators #1 6 over the K-wire; slide the matching Depth Gauge over the largest Dilator, flange positioned distally.

12 Step 3 Sequential Dilation Sequentially slide Dilators #1 6 over the K-wire; slide the matching Depth Gauge over the largest Dilator, flange positioned distally. Note: Depth Gauges may be used as pushers to advance Dilators through the musculature. Step 4 Port Measurement Rest the flange against the skin, locating the proximal end of Dilator #6 in the Depth Gauge window. Identify the necessary port length, referencing measurements on side of the Depth Gauge and rounding up. The #4 Dilator diameter correlates to a 19mm port, the #5 Dilator correlates to a 22mm port and the #6 Dilator correlates to a 26mm port. Step 5 Port Placement Remove the port from the sterile package, slide it over the Dilator and dock on the facet. Adjust the angle by wanding the Dilators. Attach the port to the Snake Arm. 9

Disc Preparation Step 6 Boney Decompression Using osteotomes and Kerrison Rongeurs, remove

Step 7 Ligamentum Flavum Mobilization Cut the ligamentum flavum from the inferior portion

Control epidural bleeding with bipolar cautery, avoiding contact with the port or other

13 Disc Preparation Step 6 Boney Decompression Using osteotomes and Kerrison Rongeurs, remove the facet and portions of the lamina. Step 7 Ligamentum Flavum Mobilization Cut the ligamentum flavum from the inferior portion of the lamina. Mobilize it with Woodson or Fine Curettes. Control epidural bleeding with bipolar cautery, avoiding contact with the port or other instruments. Step 8 Nerve Root, Dura Mobilization Free the nerve root and dura from the soft tissue; probe the boney structures with the Ball Probe. Retract the nerve root and dura. 10

14 Step 9 Annular Window Remove blood and small tissue fragments with a suction catheter; create an annular window with an annulus knife. Step 10 Remove Disc Tissue Insert the Cutting Distractors into the disc, rotating to free the disc tissue. Remove the disc fragments with Pituitary Rongeurs. Step 11 Endplate Preparation With osteotomes, remove the osteophytes and posterior lip of the adjacent vertebral bodies. Remove the remaining endplate cartilage with curettes. 11

15 Distraction Step 12 Distraction and Sizing With progressively sized Distractors, open the space to the desired height. Connect the Distractor to the Comfort T-Handle. Insert it into the space; the handle should be parallel to the vertebral endplate. Rotate its axis, opening the space to a height equal to the Distractor. 12

Channel Preparation Step 13 Option 1 Modular Rasp Option Connect the Modular Rasp to the Trial Rod. With the Rasp locked in a straight position, advance it into the disc space.

16 Channel Preparation Step 13 Option 1 Modular Rasp Option Connect the Modular Rasp to the Trial Rod. With the Rasp locked in a straight position, advance it into the disc space. Countersink, loosen the locking knob, angle the rod medially and relock the Rasp at the desired angle. Draw the rod laterally and impact it in an arcing trajectory, advancing the Rasp medially until it has traversed the midline. Fully loosen the locking knob, allowing the Rasp to freely rotate during extraction. Step 13 Option 2 Fixed Rasp Option Insert the Rasp into the disc space in an arcing trajectory until it s across the midline. The T-Handle may be attached to the Fixed Rasp stem for improved control. 13

17 Final Implant Sizing Step 14 Option 1 Modular Trial Option Connect the desired Trial to the Trial Rod. Position across the midline, adjusting the tip with the Trial Rod as described in Step 13, Option 1. Confirm final position radiographically. Step 14 Option 2 Fixed Trial Option Position the Trial across the midline. The T-Handle may be attached to the Fixed Trial stem for additional control. Confirm final position radiographically. 14

Implant Placement Step 15 Final Implant Preparation Select the implant size based on the Trial s fit. With the Bone Funnel/Bone Tamp, fill the implant with graft material.

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

19 Final Positioning Step 17 Option 1 Modular Tamp Option Connect the Modular Tamp Tip to the Trial Rod. With the Modular Tamp Tip in a straight position, mate it to the implant and tap with the Mallet to advance anteriorly, following the channel created by the Rasp. To reposition the tip, remove from disc space and turn, locking the knob to reposition. Maintain the final position while extracting the rod. Step 17 Option 2 Fixed Tamp Option Mate the Fixed Tamp to the implant and tap with the Mallet to advance anteriorly, following the channel created by a Rasp. 16

If using TraXis Vue implants, refer to the tantalum marker beads to confirm

20 Position Confirmation Step 18a Radiographic Confirmation Confirm the implant placement radiographically. If using TraXis Vue implants, refer to the tantalum marker beads to confirm orientation. Beads should appear on lateral (Fig. 18a) and A/P (Fig. 18b). Additional bone graft may be packed into the space around the implant. Step 18b 17

21 Compression Option Step 19 Implant Compression Insert rods into the pedicle screw construct, completing the assembly. Using the Compressor from the pedicle screw system, apply a load to the TraXis implant and lock the construct. 18

22 Warnings and Precautions Warnings Following are specific warnings, precautions, and adverse effects, which should be understood by the surgeon and explained to the patients. These warnings do not include all adverse effects, which can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery. 1. THE SAFETY AND EFFECTIVENESS OF INTERBODY FUSION HAS BEEN ESTABLISHED ONLY FOR SPINAL CONDITIONS WITH SIGNIFICANT MECHANICAL INSTABILITY OR DEFORMITY REQUIRING FUSION WITH INSTRUMENTATION. These conditions are significant mechanical instability secondary to degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions is unknown. (APPLICABLE ONLY TO INDICATIONS OUTSIDE THE UNITED STATES) 2. Potential risks identified with the use of this device system, which may require additional surgery, include: a) Device component fracture b) Loss of fixation c) Non-union d) Fracture of the vertebra e) Neurological injury f) Vascular or visceral injury 3. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Implants height should be determined such that adequate decompression and stability are imparted to the instrumented segment. 25

23 4. THE NEED FOR SUPPLEMENTAL FIXATION MUST BE DETERMINED BY THE SURGEON BASED UPON THE AMOUNT OF INSTABILITY IMPARTED BY THE SURGERY, AS WELL AS THE PATHOLOGY ITSELF. (APPLICABLE ONLY TO INDICATIONS OUTSIDE THE UNITED STATES) 5. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NON-UNION. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break due to fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. 6. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc. which come into contact with other metal objects, must be made from like or compatible metals. 26

24 7. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: a) The patient s weight. An overweight or obese patient can produce loads on the device that can lead to a loss of interbody height or failure of the device and/or the operation. b) The patient s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting or muscle strain, the resultant forces can cause loss of disc height and/or failure of the device. c) A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. d) Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief. e) Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. f) Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. 8. These warnings do not include all adverse effects that can occur with surgery in general. General surgical risks should be explained to the patients prior to surgery. 27

25 Precautions 1. THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SURGEONS WITH SPECIFIC TRAINING IN THE USE OF SUCH SYSTEM. THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. 2. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. 3. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of the metal implants should only be performed with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the device. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. 4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in bending or fracture. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation. 28

26 Solutions by the people of Zimmer Spine. You are devoted to helping your patients reduce their pain and improve their lives. And the people of Zimmer Spine are devoted to you. We are dedicated to supporting you with best-in-class tools, instruments and implants. We are driven by the opportunity to share our unrivaled education and training. We are committed partners who will do everything in our power to assist you in your quest to provide the absolute best in spinal care. And we can be counted on always to act with integrity as ethical partners who are worthy of your trust. We are the people of Zimmer Spine. PEEK-OPTIMA Polymer is a trademark of Victrex PLC Corporation, United Kingdom. Manufactured by: Zimmer Spine, Inc Riata Park Court Building F Austin, Texas USA Tel +1 (512) Fax +1 (512) Distributed by: Zimmer Spine Cité Mondiale 23, parvis des Chartrons Bordeaux - France Tel +33(0) Fax +33 (0) Lit. N E5AS000AN - Dec V0

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

Surgical Technique. TraXis. Precision. Transforaminal Lumbar Interbody Fusion Spacer. The Art & Science of Spine Surgery Surgical Technique Precision TraXis Transforaminal Lumbar Interbody Fusion Spacer The Art & Science of Spine Surgery Table of Contents Introduction 3 Indications 4 Key Instruments 5 Surgical Technique