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Ardis

®

Interbody System

Surgical Technique

Solutions by the people of Zimmer Spine.

zimmerspine.com

L1467 Rev A

A more advanced interbody solution.

From the people of Zimmer Spine.

The easily inserted Ardis interbody system facilitates an efficient, reproducible fusion procedure with a self-distracting nose, convex geometry and wide range of sizes. This unique interbody system is designed for versatility-it can be used in a variety of open or MIS surgical applications. Ardis comes complete with best-in-class instrumentation and is backed by the training, service and expertise that surgeons have come to expect from Zimmer Spine. A variety of options to fit your needs. And your patient's anatomy. A complete MIS solution. Ardis can be used as part of Zimmer Spine's industry-leading MIS portfolio. Minimally invasive procedures deliver less operative trauma to the patient when compared to open procedures. The benefits of this approach can include less pain and scarring, reduced operating time, accelerated patient recovery and minimized hospital stays. Zimmer Spine offers a complete MIS solution with best-in-class devices for disc preparation, access and fixation.

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Table of Contents

Indications/Contraindications Ardis Implants Harmony Instruments Ardis Instruments Surgical Technique Kit Contents Warnings and Precautions 1 3 4 5 7 14 19

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Indications/Contraindications

Indications

The Ardis Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The Ardis Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

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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. 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. Known patient sensitivity to device materials (PEEK-OPTIMA). 6. Prior fusion at the level(s) to be treated. 7. Any condition not described in the indications for use.

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Ardis Implants

Ardis' uniquely tapered nose minimizes insertion forces and provides an easy, atraumatic insertion. The device may be placed obliquely across the disc space, enabling highly efficient procedures that reduce time in the operating room. Ardis comes in 30 sizes, making it one of the most versatile interbodies in the industry. With this wide range of options, surgeons can ensure a customized fit to patient anatomy and can use the implant in a variety of surgical approaches. Length Height

Width

Ardis Implant 3201-series

9mm Width Implant

Height

Length

22mm 26mm 30mm

8mm X X X

10mm X X X

12mm X X X

14mm X X X

16mm X X X

11mm Width Implant

Height

Length

26mm 30mm 34mm Trial Sizes

8mm X X X

10mm X X X

12mm X X X

14mm X X X

16mm X X X

Height x Width

Length

22mm 26mm 30mm 34mm Trial Sizes

8x9mm X X X

8x11mm

10x9mm X X X

10x11mm

12x9mm X X X

X

Height x Width

X

12x11mm

Length

22mm 26mm 30mm 34mm X

14x9mm X X X

14x11mm

16x9mm X X X

16x11mm

X

X

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HarmonyTM Posterior Instruments

Smooth Distractors (6 - 15mm) 2654-06 to 2654-15 Incrementally distract the disc space.

Cutting Distractors (6 - 15mm) 2655-06 to 2655-15 Incrementally distract the disc space and shave vertebral endplates.

Kerrison Rongeurs (2 - 4mm) 2855-1-series, 2855-2-series Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish.

Pituitary Rongeurs (2 - 4mm) 2856-1-series, 2856-2-series Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish.

Curettes 2751-1, 2752-series, 2753-series, 2762-1, 2851-series 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.

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Ardis Instruments

Ardis' low-profile instrumentation is designed to improve visibility and precision. Each instrument has a glare-resistant coating and lengths that are conducive to both MIS and open procedures.

Shavers (6 - 16mm) 3250-06 to 3250-16 Incrementally distract the disc space and shave vertebral endplates.

Rasp, Straight 3252-01 Prepares vertebral body endplates by clearing cartilage and creating bleeding bone.

Rasp, Curved 3252-02 Prepares vertebral body endplates by clearing cartilage and creating bleeding bone.

Ardis Trials 3254-series Bullet-nosed trials in 20 sizes are utilized to estimate Ardis implant fit.

Ardis Inserter 3256-01 Inserts the implant into the disc space. Threads into the impant's posterior hole. Silver and gold knobs tighten to create a more secure inserter/implant connection.

Ardis Straight Tamp 3258-01 Advances the implant into its final position.

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Ardis Angled Tamp 3258-02 Advances the implant into its final position.

Ardis Threaded Extractor 3260-01 Removes the implant if the Inserter cannot be reattached. This instrument has aggressive threads that will deform the implant's threaded connection. A new implant should be used if the first implant is explanted.

Slaphammer 3262-01 Provides additional force in removal of Trials, Inserter or Extractor (if needed).

T-Handle, 1/4" Square Drive 3264-01 Attaches to Shavers for controlled insertion, removal and rotation.

Bone Funnel 2760-1 Bone Tamp 2755-1 Used to pack autograft material into disc space or implant.

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Surgical Technique

Preparation and Access

Step 1

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.

Step 2

Pedicle Targeting

Obtain A/P, lateral images of the affected level. Begin Harmony Port placement, accessing the facet with a Targeting Needle and K-wire.

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Step 3

Sequential Dilation

Sequentially slide Dilators #1 ­ 6 over K-wire; slide matching Depth Gauge over 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 #4, 5 or 6 in the Depth Gauge window. Identify the necessary Harmony port length, referencing the measurements on the side of the Depth Gauge and rounding up. The #4 Dilator correlates to a 19mm port, the #5 Dilator correlates to a 22mm port and the #6 Dilator correlates a 26mm port.

Step 5

Port Placement

Remove the port from its sterile package, slide over the dilator and dock it on the facet. Adjust the angle by wanding the dilators. Attach port to Snake Arm or Surgical Assist Mechanism (SAM) arm.

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Disc Space Preparation

Step 6

Boney Decompression

Using osteotomes and Kerrison Rongeurs, remove the facet and portions of the lamina.

Step 7

Ligamentum Flavum

Cut ligamentum flavum from inferior portion of lamina. Mobilize with Woodson or Fine Curettes. Control epidural bleeding with cautery, avoiding contact with the Harmony port or other instruments.

Step 8

Nerve Root, Dura Mobilization

Free the nerve root and dura from soft tissue; probe boney structures with a Ball Probe. Retract the nerve root and dura.

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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

Connect the Harmony Posterior Cutting Distractor or Ardis Shaver to its respective T-Handle and insert into the disc space; rotate it to free disc tissue. Remove disc fragments with Pituitary Rongeurs.

Note: The distance from the tip to the laser-marked line on the Ardis Shaver indicates the approximate length of a 26mm implant. The distance from its tip to the point where the gold stops indicates the approximate length of a 34mm implant.

Step 11

Endplate Preparation

With osteomes, remove osteophytes and the posterior lip of adjacent vertebral bodies. Remove remaining endplate cartilage with curettes or the Ardis Straight or Angled Rasps.

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Sizing and Placement

Step 12

Distraction

With progressively sized Harmony Smooth Distractors, Harmony Cutting Distractors or Ardis Shavers, open the disc space to the desired height. Connect a Distractor or Shaver to its respective T-Handle. Insert into the disc space and rotate its axis, opening the space to a height equal to the Distractor.

Note: The distance from the tip to the laser-marked line on the Ardis Shaver indicates the approximate length of a 26mm implant. The distance from its tip to the point where the gold stops indicates the approximate length of a 34mm implant.

Step 13

Implant Sizing

Insert a Trial into the disc space and view under fluoro to determine the proper implant size. The Slaphammer can be used to remove the Ardis trial, if necessary.

Note: TLIF approach shown. PLIF approach also possible.

Step 14

Final Implant Preparation

Select the implant size based on the Ardis Trial's fit. With the Bone Tamp, pack the implant with graft material. Ensure that the silver and gold knobs on the Inserter are flush (gold knob is proximal). Attach the implant to Inserter. First tighten the silver knob finger-tight to engage with the implant's posterior threaded hole. Then finger-tighten the gold knob to complete engagement with the implant. Use the Bone Funnel/Bone Tamp to pack autograft material into the disc space prior to inserting the implant.

Note: The silver and gold knobs must be fully engaged for secure connection of the implant to the Inserter.

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Step 15

Implant Insertion

Insert the implant into the disc space. A mallet can be used for insertion. Confirm position radiographically and detach the implant from the Inserter. First loosen the gold knob, then the silver knob (on the Inserter).

Note: Ardis is not designed to be inserted on its side and be rotated into position.

Step 16

Final Positioning

Mate either the Straight or Angled Tamp onto the posterior portion of implant. Mallet the Tamp to drive the implant in the desired direction.

Note: If using the Angled Tamp, make sure that the center nub is engaged in the posterior hole of the implant. If an implant needs to be removed from the disc space, either attempt to reengage the Inserter or thread the Extractor into the posterior threaded hole at the end of the implant. The Extractor should not be inserted at a severe angle. Engage the Extractor perpendicular to the posterior end of the implant. The Slaphammer can be used. A new implant should be implanted.

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Step 17

Position Confirmation

Confirm position radiographically. Use the Bone Funnel/Bone Tamp to pack graft material into the disc space around the implant.

Compression Option

Step 18

Implant Compression (If Necessary)

Insert rods into the pedicle screw construct, completing its assembly. Using the Compressor from the pedicle screw system kit, apply a load to the Ardis implant and lock the construct.

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Kit Contents

Module Number 2700-0001-PL3

Harmony Instrument Module

Part Number

2852-4 2854-1 2858-1 2859-1 2861-5 2861-9 2866-5 2866-9 2865-1-12 2764-1 2856-1-2 2856-1-3 2856-1-4 2856-2-2 2856-2-3 2856-2-4 2751-1 2752-1 2752-2 2752-3 2752-4 2753-2 2753-3 2762-1 2655-06 2655-07 2655-08 2655-09 2655-10 2655-11 2655-12 2655-13 2655-14 2655-15 2654-06 2654-07

Description

Penfield Dissector, small Woodson Elevator Nerve Hook-Bayonet Ball Probe-Bayonet Scoville Nerve Root Retractor, Full Angle, 5mm Scoville Nerve Root Retractor, Full Angle, 9mm Scoville Nerve Root Retractor, Bayonet, 5mm Scoville Nerve Root Retractor, Bayonet, 9mm Retractor with Suction Tip-12FR Annulus Knife Handle Pituitary Rongeur,Straight 2mm Pituitary Rongeur,Straight 3mm Pituitary Rongeur,Straight 4mm Pituitary Rongeur,Up 2mm Pituitary Rongeur,Up 3mm Pituitary Rongeur,Up 4mm Large Curette, O'Brien Large Curette, Up Angled Large Curette, Straight Large Curette, Left Large Curette, Right Down Biting Curette, Right Down Biting Curette, Left Ring Curette Cutting Distractors, 6mm Cutting Distractors, 7mm Cutting Distractors, 8mm Cutting Distractors, 9mm Cutting Distractors, 10mm Cutting Distractors, 11mm Cutting Distractors, 12mm Cutting Distractors, 13mm Cutting Distractors, 14mm Cutting Distractors, 15mm Smooth Distractors, 6mm Smooth Distractors, 7mm

Standard Kit Quantity

1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

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Harmony Instrument Module (Continued)

Part Number

2654-08 2654-09 2654-10 2654-11 2654-12 2654-13 2654-14 2654-15 1006-1 2851-1-01 2851-3-01 2851-6-01 2851-8-01 2851-9-01 2851-0-01 2763-1-1 2763-1-2 2763-1-3 2855-1-2 2855-1-3 2855-1-4 2855-2-3

Description

Smooth Distractors, 8mm Smooth Distractors, 9mm Smooth Distractors, 10mm Smooth Distractors, 11mm Smooth Distractors, 12mm Smooth Distractors, 13mm Smooth Distractors, 14mm Smooth Distractors, 15mm T-handle Small Curette, Down Straight, #1 Small Curette, Down Reverse Angle, #1 Small Curette, Up Straight, #1 Small Curette, Up Forward Angle, #1 Small Curette, Up Left, #1 Small Curette, Up Right, #1 Osteotomes, Straight Osteotomes, Angled (Curved) Osteotomes, Knife Edge Kerrison Rongeur, Forward, 2mm Kerrison Rongeur, Forward, 3mm Kerrison Rongeur, Forward, 4mm Kerrison Rongeur, Up, 3mm

Standard Kit Quantity

1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1

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Module Number 3200-0001-PL 5

Ardis Implant Module

Part Number

3201-080922 3201-080926 3201-080930 3201-081126 3201-081130 3201-081134 3201-100922 3201-100926 3201-100930 3201-101126 3201-101130 3201-101134 3201-120922 3201-120926 3201-120930 3201-121126 3201-121130 3201-121134 3201-140922 3201-140926 3201-140930 3201-141126 3201-141130 3201-141134 3201-160922 3201-160926 3201-160930 3201-161126 3201-161130 3201-161134

Description

Ardis PEEK Implant 08x09x22 Ardis PEEK Implant 08x09x26 Ardis PEEK Implant 08x09x30 Ardis PEEK Implant 08x11x26 Ardis PEEK Implant 08x11x30 Ardis PEEK Implant 08x11x34 Ardis PEEK Implant 10x09x22 Ardis PEEK Implant 10x09x26 Ardis PEEK Implant 10x09x30 Ardis PEEK Implant 10x11x26 Ardis PEEK Implant 10x11x30 Ardis PEEK Implant 10x11x34 Ardis PEEK Implant 12x09x22 Ardis PEEK Implant 12x09X26 Ardis PEEK Implant 12x09X30 Ardis PEEK Implant 12x11X26 Ardis PEEK Implant 12x11X30 Ardis PEEK Implant 12x11x34 Ardis PEEK Implant 14x09x22 Ardis PEEK Implant 14x09X26 Ardis PEEK Implant 14x09X30 Ardis PEEK Implant 14x11X26 Ardis PEEK Implant 14x11X30 Ardis PEEK Implant 14x11x34 Ardis PEEK Implant 16x09x22 Ardis PEEK Implant 16x09x26 Ardis PEEK Implant 16x09x30 Ardis PEEK Implant 16x11x26 Ardis PEEK Implant 16x11x30 Ardis PEEK Implant 16x11x34

Standard Kit Quantity

2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2

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Module Number 3200-0002-PL4

Ardis Instrument Module

Part Number

3252-01 3252-02 3258-01 3258-02 3260-01 3256-01 2760-1 2755-1 3262-01 3264-01 3250-06 3250-07 3250-08 3250-09 3250-10 3250-11 3250-12 3250-13 3250-14 3250-15 3250-16 3254-080922 3254-080926 3254-100922 3254-100926 3254-120922 3254-120926 3254-140922 3254-140926 3254-160922 3254-160926

Description

Rasp, Straight Rasp, Curved Ardis Straight Tamp Ardis Angled Tamp Ardis Threaded Extractor Ardis Inserter Bone Funnel Bone Tamp Slaphammer T-handle, 1/4" Square Drive Shaver, 06mm Shaver, 07mm Shaver, 08mm Shaver, 09mm Shaver, 10mm Shaver, 11mm Shaver, 12mm Shaver, 13mm Shaver, 14mm Shaver, 15mm Shaver, 16mm Ardis Trial 08x09x22 Ardis Trial 08x09x26 Ardis Trial 10x09x22 Ardis Trial 10x09x26 Ardis Trial 12x09x22 Ardis Trial 12x09x26 Ardis Trial 14x09x22 Ardis Trial 14x09x26 Ardis Trial 16x09x22 Ardis Trial 16x09x26

Standard Kit Quantity

1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

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Ardis Instrument Module (Continued)

Part Number

3254-080930 3254-081134 3254-100930 3254-101134 3254-120930 3254-121134 3254-140930 3254-141134 3254-160930 3254-161134

Description

Ardis Trial 08x09x30 Ardis Trial 08x11x34 Ardis Trial 10x09x30 Ardis Trial 10x11x34 Ardis Trial 12x09x30 Ardis Trial 12x11x34 Ardis Trial 14x09x30 Ardis Trial 14x11x34 Ardis Trial 16x09x30 Ardis Trial 16x11x34

Standard Kit Quantity

1 1 1 1 1 1 1 1 1 1

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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. 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. 2. 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. Use of provided trials is recommended. 3. 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.

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4. 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. 5. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. 6. 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. 7. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.

Precautions

Prior to use, the physician should be trained in the surgical procedure recommended for the use of this device. The Ardis device is a single use device and should not be reused. An explanted device should never be reimplanted.

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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.

7375 Bush Lake Road Edina, MN 55439 800.655.2614 5301 Riata Park Court, Building F Austin, Texas 78727 512.918.2700 zimmerspine.com

L1467 Rev A per DCR 6920 August 2009

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