Ardis® Interbody System Surgical Technique...A more advanced interbody solution. From the people of Zimmer Spine. The easily inserted Ardis Interbody System facilitates an efﬁcient,

Solutions by the people of Zimmer Spine.zimmerspine.com

Ardis®

Interbody System

Surgical Technique

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 and it can be used in a variety of open or MIS surgical applications. The Ardis System 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. The Ardis System 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.

Description/Indications/Contraindications 1

Ardis Implants 3

Harmony™ Posterior Instruments 4

Ardis Instruments 5

Surgical Technique 7

Kit Contents 17

Warnings and Precautions 21

Table of Contents

1

Description/Indications/Contraindications

Description

The Ardis implant is a device for interbody fusion of the anterior column of the spine. Ardis may be

used to replace the disc. These cages are hollow so that bone can grow through the device, fusing

the adjacent bony surfaces.

The Ardis implant is a hollow device with texture on two opposing convex sides, and is offered

in various lengths, widths and heights. Zimmer Spine designed the Ardis device to be placed

through a posterior or transforaminal approach and to address vertebrae in the lumbosacral

region of the spine. The system contains implants of various sizes to accommodate different

patient anatomy, and instruments for site preparation, trialing, insertion and extraction.

The device is crafted from (polyetheretherketone) PEEK-OPTIMA® (ASTM F2026). As PEEK-OPTIMA

is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK

implants. The markers consist of tantalum wires and beads (ASTM F560) that are press-fit into

small holes in the implant.

The Ardis instrumentation system is comprised of instruments and perforated instrument cases

that are generally comprised of aluminum, stainless steel, and/or polymeric materials.

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.

2

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.

3

Ardis Implants

The Ardis System’s 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.

The Ardis System comes in 48 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.

Height

Leng

th

Trial Sizes 8x 9mm

8x 11mm

9x 9mm

9x 11mm

10x 9mm

10x 11mm

11x 9mm

11x 11mm

22mm X X X X

26mm X X X X X X X X


34mm X X X X

Height x Width

Height

9mm Width Implant 8mm 9mm 10mm 11mm 12mm 13mm 14mm 16mm




Leng

th

i h id h

11mm Width Implant 8mm 9mm 10mm 11mm 12mm 13mm 14mm 16mm




Height

Leng

th

Trial Sizes 12x 9mm

12x 11mm

13x 9mm

13x 11mm

14x 9mm

14x 11mm

16x 9mm

16x 11mm

22mm X X X X



34mm X X X X

Height x Width

Leng

th

Ardis Implant 3201-series

Width

Length

4

Harmony Posterior Instruments

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.

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.

Pituitary Rongeurs (2 - 4mm) 2856-1-series, 2856-2-series

Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish.

Kerrison Rongeurs (2 - 4mm) 2855-1-series, 2855-2-series

Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish.

5

Ardis Instruments

The Ardis System’s 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.

Rasp, Curved 3252-02

Prepares vertebral body endplates by clearing cartilage and creating bleeding bone.

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.

Ardis Trials 3254-series

Bullet-nosed trials in 48 sizes are utilized to estimate Ardis implant fit.

9mm Ardis Inserter 3256-02

Inserts the 9mm implant into the disc space. Threads into the implant’s posterior hole.

11mm Ardis Inserter 3256-03

Inserts the 11mm width implant into the disc space. Threads into the implant's posterior hole.

6

Ardis Angled Tamp 3258-02

Advances the implant into its final position.

Bone Funnel 2760-1Bone Tamp2755-1

Used to pack autograft material into disc space or implant.

Slaphammer 3262-01

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

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.

T-Handle, 1/4" Square Drive 3264-02

Attaches to Shavers for controlled insertion, removal and rotation.

Ardis Straight Tamp 3258-01

Advances the implant into its final position.

7

Surgical Technique

Patient PositioningPosition 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.

Pedicle TargetingObtain A/P, lateral images of the affected level. Begin

Harmony™ Surgical Port placement, accessing the facet

with a Targeting Needle and K-wire.

Step 1

Step 2

Preparation and Access

8

Sequential DilationSequentially 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.

Port MeasurementRest 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 3

Step 4

9

Boney DecompressionUsing osteotomes and Kerrison Rongeurs, remove the

facet and portions of the lamina.

Step 6

Disc Space Preparation

Port PlacementRemove 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.

Step 5

10

Ligamentum FlavumCut 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.

Nerve Root, Dura MobilizationFree the nerve root and dura from soft tissue; probe

boney structures with a Ball Probe. Retract the nerve

root and dura.

Step 7

Step 8

11

Annular WindowRemove blood and small tissue fragments with a suction

catheter; create an annular window with an annulus

knife.

Remove Disc TissueConnect 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 9

Step 10

12

DistractionWith 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 length of a 26mm implant. The distance from its tip to the point where the gold stops indicates the length of a 34mm implant.

Step 12

Sizing and Placement

Endplate PreparationWith osteotomes, remove osteophytes and the

posterior lip of adjacent vertebral bodies. Remove

remaining endplate cartilage with curettes or the Ardis

Straight or Angled Rasps. Make sure the endplates are

well cleaned to create a surface of bleeding bone.

Step 11

13

Implant SizingInsert an Ardis 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.

Final Implant PreparationSelect the implant size based on the Ardis Trial’s fit. There

is no need to undersize or oversize the implant. With the

Bone Tamp, pack the implant with graft material. Select

the appropriate Ardis Inserter based off of the width of

the selected implant. Use the 9mm Ardis Inserter for a

9mm implant and the 11mm Ardis Inserter for an 11mm

implant. Attach the implant to the inserter by advancing

the threaded distal tip of the inserter into the implant's

posterior hole. This is accomplished by turning the knob

clockwise until it is fingertight. If it is difficult to thread,

loosen the knob, detach and reattach the implant to

prevent cross-threading. Use caution not to overtighten

the implant.

Note: Do not use the 11mm Ardis Inserter with the 9mm implant. When the correct implant is attached to the correct inserter, the posterior end of the implant will be flush against the inserter. The 11mm implant will not engage with the 9mm Ardis Inserter.

Step 13

Step 14

14

Implant InsertionInsert the implant into the disc space. A mallet can be

used for insertion. When malleting, take caution to avoid

excessive impaction force and ensure malleting occurs

on-axis. Additionally, avoid the application of torque to

the Ardis Inserter handle.

Confirm position radiographically and detach

the implant from the Inserter by turning the knob

counterclockwise until the threaded portion disengages

from the implant's posterior threaded hole.

Note: The Ardis System is not designed to be inserted on its

side and be rotated into position.

Note: If difficulty loosening the knob is encountered, the Ardis

Bone Tamp may be used to loosen the knob by engaging it with

one of the four holes in the Ardis Inserter knob. The bone tamp

should not be used to assist in tightening of the knob.

Maintain on-axis alignment between Inserter and

implants.

Step 15

Note: If difficulty loosening the knob is encountered, the Ardis

Bone Tamp may be used to loosen the knob by engaging it with

one of the four holes in the Ardis Inserter knob. The bone tamp

should not be used to assist in tightening of the knob.

15

Position ConfirmationConfirm position radiographically.

Use the Bone Funnel/Bone Tamp to pack autogenous

graft material into the disc space around the implant.

Step 17

Final PositioningMate 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.

Note: 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. The Extractor should not be used for implant insertion.

Step 16

16

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.

Step 18

Compression Option

Removal and Revision

Implant Removal or RevisionShould removal or revision of the implant be determined necessary early on post index procedure, it may still be possible

to remove the implant via the original approach. The Extractor can be used to thread into the posterior end of the implant

and be removed. The Slaphammer can be used if necessary. Once the healing process has begun, the surgeon may need

to consider alternative approaches such as direct anterior or lateral. An osteotome can be used at the interface between

the bone and both the superior and inferior faces of the implant to disengage the construct. This effectively cuts the

fused column of bone at the level of the interface. Once the implant has been disengaged, the implant can be removed.

Distraction can be used to allow easier access to the interface.

Intraoperative Implant RemovalShould removal of the device be required during surgery, the Inserter may be used to reengage the implant or the

Extractor can be used. If the Extractor is used, engage the instrument with the threaded posterior hole of the Ardis

implant and turn the handle clockwise until the threads bite into the PEEK material and the instrument is fully seated.

Connect the Slaphammer to the proximal end of the Inserter to remove the implant. Distraction will allow for easier

removal of the implant.

Note: Once the implant is removed, it should not be reinserted and a new implant should be used.

17

Kit Contents

Part Number Description Standard Kit Quantity

3201-080922 Ardis PEEK Implant 08x09x22 2






























Ardis Implant Module

Module Number 3200-0003-PL

18


3252-01 Rasp, Straight 1

3252-02 Rasp, Curved 1

3258-01 Ardis Straight Tamp 1

3258-02 Ardis Angled Tamp 1

3260-01 Ardis Threaded Extractor 1

3256-02 Ardis Inserter, 9mm 1

3256-03 Ardis Inserter, 11mm 1

2760-1 Bone Funnel 1

2755-1 Bone Tamp 1

3262-01 Slaphammer 1

3264-02 T-handle, 1/4" Square Drive 2

3250-06 Shaver, 06mm 1

3250-07 Shaver, 07mm 1

3250-08 Shaver, 08mm 1

3250-09 Shaver, 09mm 1

3250-10 Shaver, 10mm 1

3250-11 Shaver, 11mm 1

3250-12 Shaver, 12mm 1

3250-13 Shaver, 13mm 1

3250-14 Shaver, 14mm 1

3250-15 Shaver, 15mm 1

3250-16 Shaver, 16mm 1

3254-080922 Ardis Trial 08x09x22 1

3254-080926 Ardis Trial 08x09x26 1

3254-080930 Ardis Trial 08x09x30 1

3254-081126 Ardis Trial 08x11x26 1

3254-081130 Ardis Trial 08x11x30 1

3254-081134 Ardis Trial 08x11x34 1

3254-090922 Ardis Trial 09x09x22 1

3254-090926 Ardis Trial 09x09x26 1

3254-090930 Ardis Trial 09x09x30 1

3254-091126 Ardis Trial 09x11x26 1

3254-091130 Ardis Trial 09x11x30 1

3254-091134 Ardis Trial 09x11x34 1

3254-100922 Ardis Trial 10x09x22 1

3254-100926 Ardis Trial 10x09x26 1

Ardis Instrument Module


19


3254-100930 Ardis Trial 10x09x30 1

3254-101126 Ardis Trial 10x11x26 1

3254-101130 Ardis Trial 10x11x30 1

3254-101134 Ardis Trial 10x11x34 1

3254-110922 Ardis Trial 11x09x22 1

3254-110926 Ardis Trial 11x09x26 1

3254-110930 Ardis Trial 11x09x30 1

3254-111126 Ardis Trial 11x11x26 1

3254-111130 Ardis Trial 11x11x30 1

3254-111134 Ardis Trial 11x11x34 1

3254-120922 Ardis Trial 12x09x22 1

3254-120926 Ardis Trial 12x09x26 1

3254-120930 Ardis Trial 12x09x30 1

3254-121126 Ardis Trial 12x11x26 1

3254-121130 Ardis Trial 12x11x30 1

3254-121134 Ardis Trial 12x11x34 1

3254-130922 Ardis Trial 13x09x22 1

3254-130926 Ardis Trial 13x09x26 1

3254-130930 Ardis Trial 13x09x30 1

3254-131126 Ardis Trial 13x09x26 1

3254-131130 Ardis Trial 13x11x30 1

3254-131134 Ardis Trial 13x11x34 1

3254-140922 Ardis Trial 14x09x22 1

3254-140926 Ardis Trial 14x09x26 1

3254-140930 Ardis Trial 14x09x30 1

3254-141126 Ardis Trial 14x11x26 1

3254-141130 Ardis Trial 14x11x30 1

3254-141134 Ardis Trial 14x11x34 1

3254-160922 Ardis Trial 16x09x22 1

3254-160926 Ardis Trial 16x09x26 1

3254-160930 Ardis Trial 16x09x30 1

3254-161126 Ardis Trial 16x11x26 1

3254-161130 Ardis Trial 16x11x30 1

3254-161134 Ardis Trial 16x11x34 1

3290-05 Ardis Trials Outer Base 1

3290-06 Ardis General Outer Base 1

Ardis Instrument Module (Continued)


20


3290-07 Ardis Shaver Insert Tray 1

3290-22 Ardis 22 Trial Insert Tray 1




07.01260.001 Generic Stackable Lid 2

Ardis Instrument Module (Continued)


21

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.

22

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.

f) Smoking. Patients who smoke have been observed to experience higher rates of

pseudarthrosis following surgical procedures where bone graft is used.

5. 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.

6. Patients with previous spinal surgery at the level(s) to be treated may have different clinical

outcomes compared to those without a previous surgery.

23

Precautions

1. Prior to use, the physician should be trained in the surgical procedure recommended for the

use of this device.

2. The Ardis Device is a single use device and should not be reused. An explanted device should

never be reimplanted. Possible risks associated with re-use of single use devices include:

Mechanical Malfunction

Transmission of infectious agents

3. The DEVICE has not been evaluated for safety and compatibility in the MR environment. The

DEVICE has not been tested for heating or migration in the MR environment.

Instruments Warnings and Precautions

1. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean

may not be effectively sterilized.

2. Automated cleaning may not be effective. A thorough, manual cleaning process is

recommended.

3. When handling sharp instruments, use extreme caution to avoid injury.

4. Unless otherwise indicated, instrument sets are provided non-sterile and must be sterilized

prior to use.

5. Do not reuse instruments labeled for single use only. Reuse may adversely affect performance

of the instrument.

6. Flash autoclaving should be avoided whenever possible. Instruments should never be flash

autoclaved in an instrument case.

24

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.

Manufactured by:

Zimmer Spine7375 Bush Lake RoadMinneapolis, MN 55439800.655.2614

Zimmer LimitedSN3 4FP, U.K.+44.1793.58.4500

zimmerspine.com

L1467 Rev. D (07/13)(851S-1040-00) © 2013 Zimmer Spine, Inc.PEEK-OPTIMA® Polymer is a registered trademark of Invibio Ltd.

Disclaimer:This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, indications, contraindications, warnings, precautions, and adverse effects.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please see the product Instructions for Use for a complete listing of the indications, contraindications, warnings, precautions and adverse effects.

Documents

Ardis® Interbody System Surgical Technique...A more advanced interbody solution. From the people of Zimmer Spine. The easily inserted Ardis Interbody System facilitates an efﬁcient,