STRYKER SPINE VERTEBRAL SPACER

K040731 · Stryker Spine · MQP · Aug 5, 2004 · Orthopedic

Device Facts

• Record ID: K040731
• Device Name: STRYKER SPINE VERTEBRAL SPACER
• Applicant: Stryker Spine
• Product Code: MQP · Orthopedic
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine Vertebral Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Story

Vertebral body replacement implant; used in thoraco-lumbar spine (T1-L5) following total vertebrectomy for tumor or trauma; restores vertebral height; achieves anterior decompression of spinal cord/neural tissues. Implant packed with bone graft material; requires supplemental fixation (e.g., Stryker Spine plate or rod systems). Used by surgeons in clinical/OR settings. Provides structural support to replace collapsed/damaged/unstable vertebral bodies; facilitates spinal stabilization.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Vertebral body replacement device; intended for use with supplemental fixation and bone graft. Design and materials are equivalent to predicate spinal systems.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoraco-lumbar spine (T1-L5) following total vertebrectomy due to tumor or trauma. Used to restore vertebral height and achieve anterior decompression of spinal cord and neural tissues. Requires use with supplemental fixation and bone graft material.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Stryker Spine Vertebral Body Support System (K033837)
• Spinal Concepts Inc. CadenceTM and TraXisTM (K033517)
• PEEK TetrisTM Spinal Implant (K031780)
• Stackable CageTM System (K990148)
• VERTE-STACKTM Spinal System (K031780)

Submission Summary (Full Text)

{0}------------------------------------------------

| AUG - 5 2004 | 510(k) Summary of Safety and Effectiveness: |
|--------------|---------------------------------------------|
| | Stryker Spine Vertebral Spacer |

| Submitter: | Stryker Spine |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2 Pearl Court |
| | Allendale, New Jersey 07401 |
| Contact Person | Ms. Simona Voic |
| | Regulatory Affairs Project Manager |
| | Phone: [phone] |
| | FAX: [phone] |
| | Email: [e-mail] |
| Date Prepared | March 17, 2004 |
| Trade Name | Stryker Spine Vertebral Spacer |
| Classification Name<br>and Number | Spinal Vertebral Body Replacement Device,<br>21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | 1) Stryker Spine Vertebral Body Support System (K033837) |
| | 2) Spinal Concepts Inc. CadenceTM and TraXisTM (K033517) |
| | 3) PEEK TetrisTM Spinal Implant (K031780) |
| | 4) Stackable CageTM System (K990148) |
| | 5) VERTE-STACKTM Spinal System (K031780) |
| Intended Use | The Stryker Spine Vertebral Spacer is a vertebral body replacement<br>indicated for use in the thoraco-lumbar spine (T1-L5) to replace a<br>collapsed, damaged, or unstable vertebral body resected or excised<br>during total vertebrectomy procedures due to tumor or trauma, to<br>achieve anterior decompression of the spinal cord and neural tissues,<br>and to restore the height of a collapsed vertebral body.<br>It is recommended to pack bone graft material inside the implant.<br>The Stryker Spine Vertebral Spacer is intended for use with<br>supplemental fixation. The supplemental fixation systems that may |
| | be used with the Stryker Spine Vertebral Spacer include, but are not |
| | limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius |
| | 90D, and Trio). |
| Statement of | The Stryker Spine Vertebral Spacer and its predicate devices have |
| Technological | the same indications for use and are made of the same materials. |
| Comparison | Testing to demonstrate compliance with FDA's Guidance for Spinal |
| | System 510(k)'s September 27, 2000 was completed for the Stryker |
| | Spinal Vertebral Spacer. |
| Conclusion | The Stryker Spine Vertebral Spacer is substantially equivalent to its |
| | predicate devices. This conclusion is based upon the fact that this |
| | device is substantially equivalent in terms of indications for use, |
| | materials, design and principles of operation. |

{1}------------------------------------------------

.

. .

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K040731

Trade/Device Name: Stryker Spine Vertebral Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 23, 2004 Received: June 24, 2004

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regary the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices may been recassed require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manse of the Act include requirements for annual registration, listing of general voltable provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i tease of devised that I wornination that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I coclar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand by by of the Actions 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -- Ms. Simona Voic

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manceing your manoling of your device to a legally premarket nothCation. The FDA mining of basification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrice 10. Jour 201) 594-4659. Also, please note the regulation entitled, comact the Office of Complance at (597) vification" (21CFR Part 807.97). You may obtain "Misoranuning by Iciercifec to promance nouiltean and er the Act from the Division of Small other general information on your responsible in the toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Wilkinson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K040731

Device Name: Stryker Spine Vertebral Spacer

Indications For Use:

The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in The Stryker Opine Vortobial Opaved, damaged, damaged, or unstable the inoraco-iumbar Spino (11 E8) to reply to tal vertebrectomy procedures due to funnor vertebrail bouy resolou or oxcious anterior of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

It is recommended to pack bone graft material inside the implant.

The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The The Unyker Spine Vertebrans that may be used with the Stryker Spine Vertebral Supplemental likation oyetoms warter Spine plate rod or rod systems (XIA, Spiral Radius 90D, and Trio).

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

**510(k) Number** K04072