Surgical Technique

Solitaire™ Anterior Spinal System Independent Stabilization for ALIF • Available in Titanium and

Contents Introduction ...................................... Page 1 Design Features................................. Page 2 Instruments.. ..................................... Page 3 Surgical Technique............................ Page 5 Closure and Postoperative Care............ Page 10 Implant Removal............................... Page 10 Product Information.. ......................... Page 11 Indications for Use............................ Page 15 Further Information.. .......................... Page 19

B

Introduction The Solitaire ™ Anterior Spinal System, available in

range from 10mm – 20mm in titanium and 12mm – 20mm

PEEK-OPTIMA and Titanium, is designed for use with

in PEEK-OPTIMA ®, in 2mm increments, with two lordotic

autograft and is indicated for stand-alone intervertebral body

angle options, 6° and 12°.

®

fusion at one or two contiguous levels in the lumbar spine from L2 to S1.

Implants are color-coded for height, and implant color

Product Overview

Instrumentation includes instruments for site preparation,

is carried through height-specific instrumentation. implant insertion and screw fixation. The Solitaire ™ Interbody Spacer assists fusions by developing an immediate mechanical fixation to adjacent vertebral

The Solitaire ™ Anterior Spinal System is indicated for

bodies with three acute convergent angled cancellous bone

vertebral body replacement (Titanium only) and intervertebral

screws. By providing a stabile environment with a large,

fusion (both Titanium and PEEK-OPTIMA ®). When used for

single-chambered opening and subsidence resistant design,

vertebral body replacement, the Solitaire ™ Anterior Spinal

the Solitaire Interbody Spacer offers surgeons an alternative

System is indicated for use in the thoracolumbar spine

to 360° procedures.

(i.e., T10 to L5) to replace a diseased vertebral body resected

™

or excised for the treatment of tumors in order to achieve The Solitaire ™ Interbody Spacer has a large, oblong shape,

anterior decompression of the spinal cord and neural tissues,

with flat grooved superior and inferior surfaces and a large

and to restore the height of a collapsed vertebral body.

medial opening. Lateral walls are perforated in the titanium

The Solitaire ™ System is also indicated for treating fractures

implant to enhance visualization and provide proper implant

of the thoracic and lumbar spine. The Solitaire ™ System

positioning. In the PEEK implant, tantalum markers located

is designed to restore the biomechanical integrity of the

in the posterior corners serve to facilitate visualization and

anterior, middle and posterior spinal column even in the

desired implant positioning and an integrated titanium plate

absence of fusion for a prolonged period.

engages the screw locking mechanism. The posterior wall is solid to provide a stable environment for fusion, while

As an intervertebral body fusion device designed for use with

the anterior wall is perforated. The threads enable screws

autograft, the Solitaire ™ Anterior Spinal System is indicated

to develop a friction fit with the implant locking screws into

for stand-alone intervertebral body fusion at one level or

the Interbody Spacer and passing through the superior and

two contiguous levels in the lumbar spine from L2 to S1 in

inferior medial openings to fixate the Interbody Spacer with

patients with degenerative disc disease (DDD) with up to

the adjacent vertebral bodies.

Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration

There are three Solitaire Interbody Spacer footprints.

of the disc confirmed by patient history and radiographic

The three available footprints (narrow – 28mm wide,

studies. These patients should be skeletally mature and have

medium – 34mm wide, and wide – 40mm wide) allow for

had six months of non-operative treatment.

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a better anatomical fit and to help with resistance. They all have a consistent anterior end, and lateral curves designed to conform to the vertebral anatomy. The consistent anterior end enables the same instruments to be used for all implant footprints. Interbody Spacer heights

1

Design Features Designed to resist subsidence by covering 80% of the endplate Immediate mechanical fixation to adjacent vertebral body, with no vertebral column profile Acute shallow screw angle provides Large, single chamber design

strong fixation by optimizing thread

accommodates the fusion process

contact with cortical bone

Many implantation options offer intraoperative flexibility. • Three implant footprints • Variety of screw lengths • Two lordotic angles (6°, 12°) • 10mm-20mm heights NOTE: 10mm available in Titanium Only.

Narrow: 28mm wide

Medium: 34mm wide

Wide: 40mm wide

Screw Options • Screw forms friction fit to lock with spacer • 5.5mm diameter screw with lengths 20mm, 22mm, 25mm, 27mm, 30mm, 35mm (measured from the base of the head) • Cortical thread provides strong fixation with adjacent endplates and resists pullout

20mm

22mm

25mm

27mm

30mm

2

Instruments

Modular Handle

Narrow Width Trial

Medium Width Trial

Wide Width Trial

Narrow Width Rasp

Medium Width Rasp

Wide Width Rasp

Inserter Guide

3

Instruments (Continued)

Bone Graft Mold

Universal and Rigid Drills - 20mm, 25mm

Universal and Rigid Awls - 20mm, 25mm

Universal and Rigid Pentalobe Drivers

Guide Lock Tubes

Guide Lock Awls

Z-Connect Ratchet Handle

Z-Connect T-Handle Ratchet

Guide Lock Drills

Z-Connect Torque Limiting Handle

4

Surgical Technique Step 1 – Exposure

Step 3 – Trialing

Obtain anterior exposure per surgeon preference.

The optimal implant width and height can be determined

Expose and mark the midline of the intervertebral disc

by using the width and height trials. The width trials are

above and below the discectomy site and remove the entire

used first to determine the appropriate implant footprint

intervertebral disc. If performing a partial vertebrectomy,

to be utilized.

remove the disc and portion of the adjacent vertebral body or bodies according to surgeon preference.

Select the Narrow Width Trial, affix to the Modular Handle and insert into the discectomy site. If the Narrow Width Trial

Step 2 – Distraction

is too narrow, use incrementally wider footprints until an

Distraction of the discectomy site is important to restore

easily attached to the modular handle by pulling the pull

lordosis, open the neural foramen, and stabilize the implant.

pins on the handle, thus releasing the detents at the tip.

Remove the superficial layers of the cartilaginous end plates.

Then place tip inside slot on Trial.

appropriate width is achieved. (Figure 1) The Trials can be

This can be done with a variety of instruments such as scrapers, curettes, and rasps. Adequate preparation of the

Once footprint width is determined, select the 12mm Trial

endplates is important to enhance vascular supply to the

(if using the Titanium implant start with the 10mm Trial),

fusion site.

affix to the Modular Handle and insert into the fusion site. If the Trial is too small, use incrementally larger sizes until a tight fit is achieved. There should be no gaps between the prepared site and Trial. Use the largest size possible to ensure maximum stability. (Figure 2)

Figure 2

O.R. Tips: A lateral fluoro image can be utilized to illustrate posterior endplate contact with the Trial. Each 6° implant is approximately 2.62mm less at the posterior end and the 12° implants are 5.24mm less posterior when compared Figure 1

to the anterior height.

5

Surgical Technique (Continued) Step 4 – Endplate Preparation

Step 6 – Implant Preparation

Once final sizing has been determined using the appropriate

Insert implant into Bone Mold assembly, and fill with desired

Trial, utilize the appropriate sized Trial Rasp to complete

autograft material, as determined by the surgeon. This can

endplate preparation. Attach the Modular Handle to the Trial

be facilitated through use of the Bone Graft Tamp.

Rasp, and impact it into the discectomy site. Then, using the slap hammer, remove the Trial Rasp. Use the rasp in order

Graft Volume

to expose bleeding bone. (Figure 3)

Height

Lordosis

Narrow

Medium

Wide

10

6° 12°

2 2

3 3

3 3

12

6° 12°

3 3

4 4

4 4

14

6° 12°

4 4

5 5

5 5

16

6° 12°

5 5

6 6

6 6

18

6° 12°

6 6

7 7

7 7

20

6° 12°

7 7

8 8

8 8

Figure 3

CAUTION: Aggressive preparation of the endplate may remove excessive bone and weaken the endplate. Step 5 – Bone Mold Assembly Assemble the Mold Top to the Mold Base (Figure 4)

The Solitaire ™ System offers two options for preparing screw holes based on surgeon preference. Select the inserter guide that corresponds to the final implant size to be used. Inserter guides are color-coded to match a particular height of Spacer. The same inserter guide is utilized for all Spacer footprints for a particular height.

Figure 4

6

Attach implant to the inserter guide by matching the black dot on the inner part of the guide to the dot on the titanium portion of the implant (Figure 5). Hand tighten screw on guide. Attach modular handle, and use hex driver or Long T-Handle Hex guide driver to securely tighten guide to implant (Figure 6). Insert into disc space. O.R. Tip: Confirm proper orientation of guide to implant by dropping an awl or drill down one of the inserter guide tubes. The instrument should easily seat into the guide with no manipulation. (Figure 7) Alternate Screw Prep – Using GOLD Guide Lock Tubes

Figure 6

Follow above steps to attach the inserter guide to the implant. Once inserter guide is attached to implant, insert gold colored guide tubes through all three holes of inserter guide and screw into place. (Figure 8) Insert into disc space. NOTE: If using this technique, you must use the GOLD TIP Awls and Drills that are associated with the guide lock tubes. Figure 7

Figure 5

Figure 8

7

Surgical Technique (Continued) Step 7 – Implant Insertion

Step 8 – Screw Hole Preparation

Impact the implant into the fusion site, taking care to align

Insert Universal Joint or Rigid Awl into the Inserter Guide’s

the medial screw hole with the previously marked midline.

central screw hole and impact until the Awl hits the positive

Release any distractors in use to ensure implant is fully

stop. Examine the implant site using an intra-operative lateral

engaged with endplates. (Figure 9)

X-Ray to determine appropriately sized screws. The 20mm Awl length corresponds to 20mm long screws. Use the Universal Joint or Rigid Fishtail Drill with the Drill Guide if desired to further prepare for screw fixation. (Figure 10) NOTE: If gold guide lock tubes are attached you must use the GOLD tip awls and drills that correspond with this technique. (Figure 11)

Figure 9 O.R. Tips: The Solitaire ™ Interbody Implant should be countersunk 1mm-2mm in order to provide additional safety for anterior vascular structures. Imaging should be used to confirm

Figure 10

the desired position of the Solitaire ™ Interbody Implant prior to preparing screw holes.

Figure 11 O.R. Tips: If endplates are very concave, 25mm Awls and 25mm Fishtail Drills are also available and correspond to the length of the 25mm screws.

8

Step 9 – Screw Insertion

O.R. Tips:

Affix an appropriate screw to the end of the Universal Joint

•

or Rigid Pentalobe Driver. (Figure 12)

It is recommended that the Solitaire ™ Interbody Spacer should be positioned so that one screw is inserted into the superior vertebral body and two screws are inserted into the inferior vertebral body. However, testing was conducted with the Solitaire ™ Interbody Spacer ‘upside down’, so it can be used in this configuration

• Inserter Guide may be removed intra-operatively in order to visualize positioning of the implant and screws within the vertebral body under fluoroscopy

Figure 12 Step 10 – Final Tightening

• Final tightening (torquing) of screws can be done with or without inserter guide attached • Use the slap hammer to disengage the driver from the screw after torquing

NOTE: If using the gold guide lock tubes to prep the holes they need to be removed at this time. Place the screw into the central screw hole on the Inserter Guide. Insert each screw until solid engagement of the cancellous thread occurs. Torque each screw to ensure engagement of the locking mechanism. The Torque Limiting Handle ‘clicks’ at approximately 55in-lb of force. (Figure 13) Additional autograft material may then be placed in front of the implant.

Figure 13

9

Surgical Technique (Continued) Closure and Postoperative Care

Implant Removal

A routine wound closure is then performed.

Should it become necessary to remove the Solitaire ™ Spacer,

• Routine monitoring of the vital signs, and of the hemodynamic and neurologic status of the patient

the following guidelines should be observed:

• Pain medication

1. Soft tissue on the anterior surface of the implant should

• NG tubes and/or Foley catheters are discontinued within 24 - 48 hours



be removed.

2. Initially, Universal or Rigid Drivers should be used

• Diet is restricted to small amounts of liquids until return of bowel function is completed



• The patient is encouraged to ambulate as soon as possible. The individual surgeon determines activity level

3. Should screws become stripped, Screw Remover should

to remove screws.

be used to remove screws.

• Braces are to be used at each surgeon’s discretion 4. Once screws are removed, Implant Remover should

be utilized to remove implant from wound site.

10

Product Information Solitaire™ PEEK Implants – Catalog # 14-530141 Catalog #

Description

Qty/Kit

Catalog #

Description

Qty/Kit

14-530011 PEEK Implant – 6° 12mm Narrow

2

14-530071 PEEK Implant – 6° 12mm Wide

2

14-530012 PEEK Implant – 6° 14mm Narrow

2

14-530072 PEEK Implant – 6° 14mm Wide

2

14-530013 PEEK Implant – 6° 16mm Narrow

2

14-530073 PEEK Implant – 6° 16mm Wide

2

14-530014 PEEK Implant – 6° 18mm Narrow

2

14-530074 PEEK Implant – 6° 18mm Wide

2

14-530015 PEEK Implant – 6° 20mm Narrow

0*

14-530075 PEEK Implant – 6° 20mm Wide

0*

14-530021 PEEK Implant – 12° 12mm Narrow

2

14-530081 PEEK Implant – 12° 12mm Wide

2

14-530022 PEEK Implant – 12° 14mm Narrow

2

14-530082 PEEK Implant – 12° 14mm Wide

2

14-530023 PEEK Implant – 12° 16mm Narrow

2

14-530083 PEEK Implant – 12° 16mm Wide

2

14-530024 PEEK Implant – 12° 18mm Narrow

2

14-530084 PEEK Implant – 12° 18mm Wide

2

14-530025 PEEK Implant – 12° 20mm Narrow

0*

14-530085 PEEK Implant – 12° 20mm Wide

0*

14-530041 PEEK Implant – 6° 12mm Medium

2

14-530042 PEEK Implant – 6° 14mm Medium

2

14-530043 PEEK Implant – 6° 16mm Medium

2

14-530044 PEEK Implant – 6° 18mm Medium

2

14-530045 PEEK Implant – 6° 20mm Medium

0*

14-530051 PEEK Implant – 12° 12mm Medium

2

14-530052 PEEK Implant – 12° 14mm Medium

2

14-530053 PEEK Implant – 12° 16mm Medium

2

14-530054 PEEK Implant – 12° 18mm Medium

2

14-530055 PEEK Implant – 12° 20mm Medium

0*

* Denotes Special Order Item

11

Product Information (Continued) Solitaire™ Titanium Implants – Catalog # 55500162 Catalog #

Description

Qty/Kit

Catalog #

Description

Qty/Kit

1400-0600 Ti Implant – 6° 10mm Narrow

2

1400-1230 Ti Implant – 12° 10mm Medium

2

1400-0602 Ti Implant – 6° 12mm Narrow

2

1400-1232 Ti Implant – 12° 12mm Medium

2

1400-0604 Ti Implant – 6° 14mm Narrow

2

1400-1234 Ti Implant – 12° 14mm Medium

2

1400-0606 Ti Implant – 6° 16mm Narrow

2

1400-1236 Ti Implant – 12° 16mm Medium

2

1400-0608 Ti Implant – 6° 18mm Narrow

2

1400-1238 Ti Implant – 12° 18mm Medium

2

1400-0609 Ti Implant – 6° 20mm Narrow

0*

1400-1239 Ti Implant – 12° 20mm Medium

0*

1400-1200 Ti Implant – 12° 10mm Narrow

2

1400-0650 Ti Implant – 6° 10mm Wide

2

1400-1202 Ti Implant – 12° 12mm Narrow

2

1400-0652 Ti Implant – 6° 12mm Wide

2

1400-1204 Ti Implant – 12° 14mm Narrow

2

1400-0654 Ti Implant – 6° 14mm Wide

2

1400-1206 Ti Implant – 12° 16mm Narrow

2

1400-0656 Ti Implant – 6° 16mm Wide

2

1400-1208 Ti Implant – 12° 18mm Narrow

2

1400-0658 Ti Implant – 6° 18mm Wide

2

1400-1209 Ti Implant – 12° 20mm Narrow

0*

1400-0659 Ti Implant – 6° 20mm Wide

0*

1400-0630 Ti Implant – 6° 10mm Medium

2

1400-1250 Ti Implant – 12° 10mm Wide

2

1400-0632 Ti Implant – 6° 12mm Medium

2

1400-1252 Ti Implant – 12° 12mm Wide

2

1400-0634 Ti Implant – 6° 14mm Medium

2

1400-1254 Ti Implant – 12° 14mm Wide

2

1400-0636 Ti Implant – 6° 16mm Medium

2

1400-1256 Ti Implant – 12° 16mm Wide

2

1400-0638 Ti Implant – 6° 18mm Medium

2

1400-1258 Ti Implant – 12° 18mm Wide

2

1400-0639 Ti Implant – 6° 20mm Medium

0*

1400-1259 Ti Implant – 12° 20mm Wide

0*

*Denotes Special Order Item

12

Solitaire™ Standard Instruments/Implants – Catalog #

Catalog # 14-530148 Catalog #

Description

Description

Qty/Kit

Qty/Kit

1400-9530 Trial 10mm, 12° Narrow

1

1400-9750 Inserter Guide 10mm

1

1400-9532 Trial 12mm, 12° Narrow

1

1400-9752 Inserter Guide 12mm

1

1400-9534 Trial 14mm, 12° Narrow

1

1400-9754 Inserter Guide 14mm

1

1400-9536 Trial 16mm, 12° Narrow

1

1400-9756 Inserter Guide 16mm

1

1400-9538 Trial 18mm, 12° Narrow

1

1400-9758 Inserter Guide 18mm

1

1400-9539 Trial 20mm, 12° Narrow

0**

1400-9465 Hex Guide Driver

1

1400-9132 20mm Universal Awl

1

1400-9550 Trial 10mm, 6° Medium

1

1400-9451 20mm Rigid Awl

1

1400-9552 Trial 12mm, 6° Medium

1

1400-9212 20mm Rigid Drill (Fishtail)

1

1400-9554 Trial 14mm, 6° Medium

1

1400-9222 20mm Universal Drill (Fishtail)

1

1400-9556 Trial 16mm, 6° Medium

1

14-530144 Pentalobe Driver, Rigid

1

1400-9558 Trial 18mm, 6° Medium

1

14-530145 Pentalobe Driver, U-Joint

1

1400-9559 Trial 20mm, 6° Medium

0**

1400-9270 T-Handle, Ratchet, Z-Connect

1

1300-9004 Torque T-Handle

1

1400-9560 Trial 10mm, 12° Medium

1

1400-9490 Screw Remover

1

1400-9562 Trial 12mm, 12° Medium

1

14-530106 Pentalobe Screws – 20mm

10

1400-9564 Trial 14mm, 12° Medium

1

14-530108 Pentalobe Screws – 22mm

10

1400-9566 Trial 16mm, 12° Medium

1

14-530111 Pentalobe Screws – 25mm

10

1400-9568 Trial 18mm, 12° Medium

1

14-530113 Pentalobe Screws – 27mm

10

1400-9569 Trial 20mm, 12° Medium

0**

14-530116 Pentalobe Screws – 30mm

10

14-530121 Pentalobe Screws – 35mm

0*

1400-9590 Trial 10mm, 12° Wide

1

1400-9592 Trial 12mm, 12° Wide

1

1

1400-9594 Trial 14mm, 12° Wide

1

560169

Ionic 30° Distractor Handle A

560170

Ionic 30° Distractor Handle B

1

1400-9596 Trial 16mm, 12° Wide

1

560189

AIS Anterior Distractor Large

1

1400-9598 Trial 18mm, 12° Wide

1

560198

Ionic Single Tip A

1

1400-9599 Trial 20mm, 12° Wide

0**

560199

Ionic Single Tip B

1

® ®

® ®

1000-9007 Slotted Mallet

1

1400-9630 Rasp 10mm, 12° Narrow

1

1400-9280 Straight Handle, Ratchet, Z-Connect

1

1400-9632 Rasp 12mm, 12° Narrow

1

1400-9290 Implant Removal Tool

1

1400-9634 Rasp 14mm, 12° Narrow

1

1400-9636 Rasp 16mm, 12° Narrow

1

1000-9010 Bone Graft Tamp

1

1400-9638 Rasp 18mm, 12° Narrow

1

1400-9167 Template Mold Base

1

1400-9639 Rasp 20mm, 12° Narrow

0**

1400-9170 Bone Mold Base

1

1400-9470 Modular Handle

2

*Denotes Special Order Item **Supplemental Tray

13

Product Information (Continued) Solitaire™ Standard Instruments Catalog #

Catalog # 14-530148 (Continued) Catalog #

Description

Qty/Kit

Description

Qty/Kit

1400-9520 Trial 10mm, 6° Narrow

1

1400-9659 Rasp 10mm, 12° Medium

1

1400-9522 Trial 12mm, 6° Narrow

1

1400-9660 Rasp 12mm, 12° Medium

1

1400-9524 Trial 14mm, 6° Narrow

1

1400-9662 Rasp 14mm, 12° Medium

1

1400-9526 Trial 16mm, 6° Narrow

1

1400-9664 Rasp 16mm, 12° Medium

1

1400-9528 Trial 18mm, 6° Narrow

1

1400-9666 Rasp 18mm, 12° Medium

1

1400-9529 Trial 20mm, 6° Narrow

1

1400-9669 Rasp 20mm, 12° Medium

0**

1400-9539 Trial 20mm, 12° Narrow

1

1400-9569 Trial 20mm, 12° Medium

1

1400-9690 Rasp 10mm, 12° Wide

1

1400-9580 Trial 10mm, 6° Wide

1

1400-9692 Rasp 12mm, 12° Wide

1

1400-9582 Trial 12mm, 6° Wide

1

1400-9694 Rasp 14mm, 12° Wide

1

1400-9584 Trial 14mm, 6° Wide

1

1400-9696 Rasp 16mm, 12° Wide

1

1400-9586 Trial 16mm, 6° Wide

1

1400-9698 Rasp 18mm, 12° Wide

1

1400-9588 Trial 18mm, 6° Wide

1

1400-9699 Rasp 20mm, 12° Wide

0**

1400-9589 Trial 20mm, 6° Wide

1

1400-9599 Trial 20mm, 12° Wide

1

1400-9620 Rasp 10mm, 6° Narrow

1

Solitaire Supplemental Instruments ™

Catalog # 14-531320

1400-9622 Rasp 12mm, 6° Narrow

1

Description

Qty/Kit

1400-9624 Rasp 14mm, 6° Narrow

1

14-530143 T-Handle Hex Guide Driver

1

1400-9626 Rasp 16mm, 6° Narrow

1

14-531300 Guidelock Tubes (Gold)

3

1400-9628 Rasp 18mm, 6° Narrow

1

14-531301 Guidelock Drill, 20mm Rigid

1

1400-9629 Rasp 20mm, 6° Narrow

1

14-531302 Guidelock Drill, 25mm Rigid

1

1400-9650 Rasp 10mm, 6° Medium

1

14-531304 Guidelock Drill, 20mm U-Joint

1

1400-9652 Rasp 12mm, 6° Medium

1

14-531305 Guidelock Drill, 25mm U-Joint

1

1400-9654 Rasp 14mm, 6° Medium

1

14-531307 Guidelock Awl, 20mm Rigid

1

1400-9656 Rasp 16mm, 6° Medium

1

14-531308 Guidelock Awl, 25mm Rigid

1

1400-9658 Rasp 18mm, 6° Medium

1

14-531310 Guidelock Awl, 20mm U-Joint

1

1400-9659 Rasp 20mm, 6° Medium

1

14-531311 Guidelock Awl, 25mm U-Joint

1

1400-9669 Rasp 20mm, 12° Medium

1

Catalog #

1400-9133 25mm Universal Awl

1

1400-9680 Rasp 10mm, 6° Wide

1

1400-9452 25mm Rigid Awl

1

1400-9682 Rasp 12mm, 6° Wide

1

1400-9213 25mm Rigid Drill (Fishtail)

1

1400-9684 Rasp 14mm, 6° Wide

1

1400-9223 25mm Universal Drill (Fishtail)

1

1400-9686 Rasp 16mm, 6° Wide

1

1400-9688 Rasp 18mm, 6° Wide

1

1400-9689 Rasp 20mm, 6° Wide

1

1400-9699 Rasp 20mm, 12° Wide

1

1400-9760 Inserter Guide 20mm

1

**Supplemental Tray

14

Indications for Use The Solitaire ™ and Solitaire ™ PEEK Anterior Spinal System

The longitudinal walls located on the top and bottom of the

is designed for use with autograft and is indicated for

device are lordotically shaped for optimum surface contact

stand-alone intervertebral body fusion at one level or two

with the vertebral body. Both the Solitaire ™ and Solitaire ™

contiguous levels in the lumbar spine from L2 to S1 in

PEEK Anterior Spinal System is intended to provide stability

patients with degenerative disc disease (DDD) with up to

within the axis of the spine, thereby creating an environment

Grade 1 spondylolisthesis at the involved level(s). DDD is

for a successful spinal fusion and pain relief for the patient.

defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic

The Solitaire ™ Anterior Spinal System device is available in

studies. These patients should be skeletally mature and have

height sizes from 10mm-20mm and is made from titanium

had six months of non-operative treatment.

alloy (Ti-6A1-4V ELI), conforming to ASTM Standard F136.

Additionally, the Solitaire ™ Anterior Spinal System is

made from stainless steel, conforming to ASTM Standard

indicated for use in the thoracolumbar spine (i.e., T10 to

F899. The Solitaire ™ PEEK Anterior Spinal System is available

L5) to replace a diseased vertebral body resected or excised

in height sizes from 12mm-20mm and is made from PEEK-

for the treatment of tumors in order to achieve anterior

OPTIMA ® as described by ASTM F-2026. The radio-opaque

decompression of the spinal cord and neural tissues, and

markers are tantalum and are made to the voluntary standard

to restore the height of a collapsed vertebral body. The

ASTM F-560. The threaded insert is made from titanium

Solitaire System is also indicated for treating fractures

alloy (Ti-6Al-4V ELI), conforming to ASTM Standard F-136.

Instruments designed for implantation of the device are

™

of the thoracic and lumbar spine. The Solitaire System

Instruments designed for implantation of the device are

is designed to restore the biomechanical integrity of the

made from stainless steel, conforming to ASTM Standard

anterior, middle and posterior spinal column even in the

F899 and other medical grade materials.

™

absence of fusion for a prolonged period. The Solitaire ™ and Solitaire ™ PEEK Anterior spacers may Description of Device

be used with the Solitaire ™ Osseotite ® screws. These screws have a roughened surface created by the proprietary

The Solitaire Anterior Spinal System is a device with an oval ™

Osseotite ® process.

shape with perforated walls and an open top and bottom design. The system consists of a spacer with three bone

Instructions-for-Use

screws. The Solitaire PEEK Anterior Spinal Spacer is a ™

device with an oval shape with walls and an open top and

CAUTION: The Solitaire ™ and Solitaire ™ PEEK Anterior

bottom design. The PEEK system consists of a spacer with

Spinal System should only be implanted by surgeons who

radiographic markers and bone screws for intervertebral

are fully experienced in the use of such implants and the

body fusion. The walls provide structural integrity while

required specialized spinal surgical techniques. Refer to

the opening at the top and bottom of the device allows for

the Solitaire ™ and Solitaire ™ PEEK Anterior Spinal System

bone growth through the interior of the device. The top and

Surgical Technique for complete Instructions-for-Use. For

bottom walls i.e., rims, have serrated teeth that grip into the

a copy of the surgical technique, please contact your sales

endplates of the vertebral body to reduce implant migration.

representative at the address provided below.

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Indications for Use (Continued) Contraindications

Warnings

Contraindications include, but are not limited to, infection,

The surgeon should be aware of the following:

systemic, spinal or localized; morbid obesity; signs of

1. The correct selection of the implant is extremely

local inflammation; fever or leukocytosis; metal sensitivity/

important. The potential for success is increased by

allergies to the implant materials; any medical or surgical

the selection of the proper size, shape and design of

condition which would preclude the potential benefit of spinal

the implant. The size and shape of the human spine

implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital abnormalities; rapid joint disease, bone absorption, osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication

presents limiting restrictions of the size and strength of implants. No implant can be expected to withstand the unsupported stresses of full weight bearing. 2. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. The device must be handled and stored carefully, protected from damage, including from corrosive environments. They

since this condition may limit the degree of obtainable

should be carefully unpacked and inspected for damage

correction, the amount of mechanical fixation, and/or the

prior to use.

quality of the bone graft); any case not needing a bone graft and fusion or where fracture healing is not required; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the

3. All instruments must be cleaned and sterilized prior to surgery. 4. Do not reuse implants/devices. While an implant/device may appear undamaged, previous stress may have

operative site or where there is inadequate bone stock, bone

created imperfections that would reduce the service life

quality, or anatomical definition; any case not described in

of the implant/device. Do not treat patients with implants/

the indications; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with anatomical structures or expected physiological performance and prior fusion at the level(s) to be treated.

devices that have been even momentarily placed in or used on a different patient. 5. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences. 6. Postoperative care is important. The patient should be instructed in the limitations of his/her implant and should be cautioned regarding weight bearing and body stress on the appliance prior to secure bone healing. 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. 8. The Solitaire ™ and Solitaire ™ PEEK Anterior Spinal System has not been evaluated for safety and compatibility in the M.R. environment. The Solitaire ™ and Solitaire ™ PEEK Anterior Spinal System has not been tested for heating or migration in the M.R. environment.

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Precautions

The patient should be warned to avoid falls or sudden jolts in spinal position. To allow maximum chances for

Preoperative: Only patients that meet the criteria described

a successful surgical result, the patient or device should

in the indications should be selected. Patient conditions

not be exposed to mechanical vibrations that may loosen

and/or pre-dispositions such as those addressed in the

the device construct. The patient should be warned of

Contraindications Section should be avoided. Care should be

this possibility and instructed to limit and restrict physical

used in the handling and storage of the implant components.

activities, especially lifting, twisting motions and any type

The implants should not be scratched or otherwise damaged.

of sport participation. The patient should be advised not to

Implants and instruments should be protected during storage

smoke or consume alcohol during the bone graft healing

especially from corrosive environments. All instruments

process. If a nonunion develops or if the components

should be cleaned and sterilized before use.

loosen, bend, and/or break, the device(s) should be revised and/or removed immediately before serious injury occurs.

Intraoperative: Any instruction manuals should be carefully

Failure to immobilize a delayed or nonunion of bone will

followed. At all times, extreme caution should be used

result in excessive and repeated stresses on the implant.

around the spinal cord and nerve roots. Damage to nerves

By the mechanism of fatigue these stresses can cause

may occur resulting in a loss of neurological functions. Bone

eventual bending, loosening, or breakage of the device(s).

grafts may be placed in the area to be fused.

It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and

Postoperative: The physician’s postoperative directions

confirmed by radiographic examination. The patient must be

and warnings to the patient and the corresponding patient

adequately warned of these hazards and closely supervised

compliance are extremely important. Detailed instructions on

to ensure cooperation until bony union is confirmed. Any

the use and limitations of the device should be given to the

retrieved devices should be treated in such a manner that

patient. If partial weight-bearing is recommended or required

reuse in another surgical procedure is not possible. As with

prior to firm bony union, the patient must be warned that

all orthopaedic implants, none of the Solitaire ™ and Solitaire ™

bending, loosening or breakage of the components are

PEEK Anterior Spinal System components should ever be

complications which can occur as a result of excessive or

reused under any circumstances.

early weight-bearing or excessive muscular activity. The risk of bending, loosening, or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other such weight supporting devices.

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Indications for Use (Continued) Potential Adverse Effects and Complications

Sterilization

Possible adverse effects include, but are not limited

The Solitaire ™ PEEK spacer and the Solitaire ™ Osseotite ®

to, bending, loosening or fracture of the implants or

screws are provided sterile. The product is gamma radiation

instruments; loss of fixation; sensitivity to a metallic foreign

sterilized. The package should be inspected prior to use to

body, including possible tumor formation; skin or muscle

ensure the sterile barrier has not been compromised.

sensitivity in patients with inadequate tissue coverage over

Do not resterilize.

the operative site, which may result in skin breakdown and/or wound complications; nonunion or delayed union; infection;

The Solitaire ™ Titanium spacer and the Solitaire ™ screws

nerve or vascular damage due to surgical trauma, including

are provided non-sterile and must be sterilized prior to

loss of neurological function, dural tears, radiculopathy,

use. All packaging materials must be removed prior to

paralysis and cerebral spinal fluid leakage; gastrointestinal,

sterilization. The following steam sterilization parameters

urological and/or reproductive system compromise,

are recommended:

including sterility, impotency and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress

Cycle:

shielding, or bone fracture at, above or below the level or

Temperature: 270°F/132°C

High Vacuum

surgery (fracture of the vertebra); hemorrhage of blood

Time:

8 minutes

vessels and/or hematomas; malalignment of anatomical

Drying time:

20 minutes

structures, including loss of proper spinal curvature,

Note:

Allow for cooling

correction, reduction and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily

Individuals not using the recommended method, temperature

living; reoperation or death.

and time are advised to validate any alternative methods or cycles using an approved method or standard.

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Further Information CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. The Solitaire ™ Anterior Spinal System Surgical Technique is presented to demonstrate the surgical technique utilized by J. Abbott Byrd, III, M.D. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. For further information, please contact the Customer Service Department at: Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054 973.299.9300 • 800.526.2579 www.biometspine.com

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Notes:

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C

At Biomet, engineering excellence is our heritage and our passion. For over 25 years, through various divisions worldwide, we have applied the most advanced engineering and manufacturing technology to the development of highly durable systems for a wide variety of surgical applications.

Solitaire ™ Anterior Spinal System Independent Stabilization for ALIF To learn more about this product, contact your local Biomet Sales Representative today.

100 Interpace Parkway • Parsippany, NJ 07054 800.526.2579 • www.biometspine.com • BSP228034L 06/10 ©2010 EBI, LLC. All trademarks are the property of Biomet, Inc. or one of its subsidiaries unless otherwise indicated. U.S. Patent No. 7,077,864. PEEK-OPTIMA ® is a registered trademark of Invibio ® Biomaterial Solutions. Rx Only.