THOR ANTERIOR PLATING SYSTEM

K073437 · Stryker Spine · KWQ · Feb 13, 2008 · Orthopedic

Device Facts

• Record ID: K073437
• Device Name: THOR ANTERIOR PLATING SYSTEM
• Applicant: Stryker Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine THOR™ Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Stryker Spine THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Trauma (i.e., fracture or dislocation); Deformities (i.e. scoliosis or lordosis); Spinal Stenosis; and Failed Previous Fusion.

Device Story

Anterior/anterolateral spinal fixation system; consists of titanium alloy plates and bone screws. Plates feature anatomical design; preassembled with rings for screw insertion. Used in lumbar/lumbosacral spine (L1-S1) to provide supplemental support during fusion procedures. Implanted by surgeons via lateral, anterolateral, or anterior surgical approaches. Provides mechanical stabilization to the spinal column to facilitate fusion; benefits patients by addressing acute/chronic instabilities or deformities.

Clinical Evidence

Bench testing only. Mechanical performance testing performed in compliance with FDA's Guidance for Spinal System 510(k)s (May 3, 2004) demonstrated equivalent performance to predicate devices.

Technological Characteristics

Titanium alloy plates and bone screws; anatomical plate design with preassembled rings. Mechanical performance equivalent to predicate spinal systems. Biocompatible materials.

Indications for Use

Indicated for skeletally mature patients requiring lumbar/lumbosacral (L1-S1) stabilization during fusion with autograft/allograft for degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, trauma (fracture/dislocation), deformities (scoliosis/lordosis), spinal stenosis, or failed previous fusion.

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

• Synthes Anterior Tension Band System (K022791)
• Stryker Spine CENTAUR Spinal System (K994347, K001844)
• Stryker Spine Xia Stainless Steel System (K012870)

Submission Summary (Full Text)

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Stryker Spine THOR™ Anterior Plating System

Traditional 510(k) Premarket Notification

### 510(k) Summary: THOR™ Anterior Plating System

| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FEB 13 20 |
| Contact Person | Mr. Curtis Truesdale<br>Regulatory Affairs Project Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | February 8, 2008 |
| Trade Name | Stryker Spine THORTM Anterior Plating System |
| Proposed Class | Class II |
| Classification Name<br>and Number | Spinal Intervertebral Body Fixation Orthosis<br>21 CFR 888.3060 |
| Product Code | KWQ |
| Predicate Devices | Synthes Anterior Tension Band System: 510(k) #K022791<br>Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844<br>Stryker Spine Xia Stainless Steel System: 510(k) #K012870 |
| Device Description | The Stryker Spine THORTM Anterior Plating System is designed<br>for anterior and anterolateral stabilization of the lumbar and<br>lumbosacral spine (L1-S1). The system consists of a variety of<br>plates and bone screws manufactured from Titanium alloy. The<br>plates have an anatomical shape design and are preassembled<br>with rings to accommodate the insertion of bone screws. |
| Summary of the | Testing in compliance with FDA's Guidance for Spinal System |
| Technological<br>Characteristics | 510(k)'s May 3, 2004 was performed for the THOR TM Anterior |
| | Plating System, and demonstrated equivalent mechanical<br>performance characteristics to the Stryker Spine CENTAUR<br>Spinal System [510(k) K994347, K001844] and Stryker Spine<br>Xia Stainless Steel System [510(k) K012870]. THORTM system<br>demonstrated equivalent material biocompatibility to the Stryker<br>Spine CENTAUR Spinal System indicated above and is<br>equivalent to the Synthes Anterior Tension Band System [510(k<br>K022791] with respect to intended use. |

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The Stryker Spine THOR™ Anterior Plating System is indicated Intended Use for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.

> THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Trauma (i.e., fracture or dislocation); Deformities (i.e. scoliosis or lordosis); Spinal Stenosis; and Failed Previous Fusion.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

## FEB 13 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K073437

Trade/Device Name: THORTM Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 5, 2007 Received: December 6, 2007

Dear Mr. Truesdale:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Mr. Curtis Truesdale

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Stryker Spine THOR™ Anterior Plating System

Traditional 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known): K_

Device Name: Stryker Spine THOR™ Anterior Plating System

Indications For Use:

The Stryker Spine THOR™ Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.

The Styker Spine THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

- Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Pseudoarthrosis; .
- Spondylolysis; .
- Spondylolisthesis; .
- Trauma (i.e., fracture or dislocation); .
- Deformities (i.e., scoliosis or lordosis)
- Spinal Stenosis; and
- Failed Previous Fusion. ●

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

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)

barbare Buelud
(Division Sign-Off)
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**510(k) Number** K073437