THOR ANTERIOR PLATING SYSTEM

K080773 · Stryker Spine · KWQ · Jun 9, 2008 · Orthopedic

Device Facts

• Record ID: K080773
• Device Name: THOR ANTERIOR PLATING SYSTEM
• Applicant: Stryker Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (L1-S1), THOR Anterior Plating System is intended 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 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: 1) Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Trauma (i.e., fracture or dislocation); 6) Deformities (i.e. scoliosis or lordosis); 7) Spinal Stenosis; and 8) Failed Previous Fusion. When used as an anterolateral non-pedicle fixation system, in the thoracic and thoracolumbar spine (TI-L5), 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: 1) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); 2) Trauma (i.e. Fracture or Dislocation); 3) Spinal Stenosis; 4) Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis); 5) Tumors; 6) Failed Previous Fusion.

Device Story

THOR Anterior Plating System provides anterior/anterolateral stabilization of thoracic, lumbar, and sacral spine. System comprises titanium alloy plates and bone screws; plates feature preassembled locking rings to secure screws. Used by surgeons in clinical settings to provide supplemental support during spinal fusion procedures. Device stabilizes spine segments to facilitate bone healing; benefits patients by addressing acute/chronic instabilities or deformities. Output is mechanical fixation of spinal segments.

Clinical Evidence

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

Technological Characteristics

Materials: Titanium alloy. Components: Plates with preassembled locking rings and bone screws. Principle: Mechanical spinal intervertebral body fixation. Connectivity: None (mechanical device). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring anterior/anterolateral non-pedicle spinal fixation (T1-S1) for degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis), tumors, or failed previous fusion, used with autograft or allograft.

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 CENTAUR Spinal System (K994347, K001844)
• Stryker Spine Xia Stainless Steel System (K012870)
• Stryker Spine THOR Anterior Plating System (K073437)

Submission Summary (Full Text)

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h0773

Stryker Spine THOR™ Anterior Plating System

Traditional 510(k) Premarket Notification

JUN - 9 2008 510(k) Summary: THOR™ Anterior Plating System

Stryker Spine Submitter: 2 Pearl Court Allendale, New Jersey 07401

Mr. Curtis Truesdale Contact Person Regulatory Affairs Project Manager Phone: [phone] FAX: [phone] Email: curtis.truesdale(@stryker.com

March 17, 2008 Date Prepared

Stryker Spine THORTM Anterior Plating System Trade Name Class II Proposed Class Spinal Intervertebral Body Fixation Orthosis Classification Name 21 CFR 888.3060 and Number KWQ Product Code

- Stryker Spine THOR Anterior Plating System: 510(k) #K073437 Predicate Devices Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870
- The Stryker Spine THOR™ Anterior Plating System is designed Device Description for anterior and anterolateral stabilization of the thoracic, lumbar and sacral spine. The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates are preassembled with locking rings to accommodate the insertion of bone screws.

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## Indications for Use (continued)

When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), 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:

- 1) Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- 2) Trauma (i.e. Fracture or Dislocation)
- 3) Spinal Stenosis
- 4) Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
- 5) Tumors
- 6) Failed Previous Fusion

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Intended Use When used as an anterior non-pedicle fixation system, in the lumbar and lumbosacral spine (L1-S1), THOR™ Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. 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.

When used as an anterolateral non-pedicle fixation system, in the thoracic and thoracolumbar spine (TI-L5), 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 degenerative disc confirmed by history and radiographic studies);

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- Trauma (i.e. fracture or dislocation); .
- Spinal stenosis; .
- Deformities (i.e. scoliosis, kyphosis and/or lordosis); .
- Tumors; and .
- Failed Previous Fusion. .

| Summary of the<br>Technological<br>Characteristics | Testing in compliance with FDA's Guidance for Spinal System<br>510(k)'s May 3, 2004 was performed for the THORTM Anterior<br>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]. The subject<br>THORTM system demonstrated equivalent material<br>biocompatibility and intended use as the Stryker Spine<br>CENTAUR Spinal System and the previously cleared THORTM<br>Anterior Plating System [510(k) K073437]. |
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN - 9 2008

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

Re: K080773

> Trade/Device Name: THOR Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: March 17, 2008 Received: March 19, 2008

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 M. Millman

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 THORTM Anterior Plating System

### Indications for Use

510(k) Number (if known): K 080773

Device Name: Stryker Spine THOR™ Anterior Plating System

Indications for Use:

When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (L1-S1), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. 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:

- 1) Degenerative Disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- 2) Pseudoarthrosis
- 3) Spondylolysis
- Spondyloisthesis 4)
- Trauma (i.e. Fracture of Dislocation) 5)
- Deformities (i.e. Scoliosis or Lordosis) 6)
- Spinal Stenosis 7)
- Failed previous Fusion 8)

### INDICATIONS CONTINUE ON NEXT PAGE

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Neil R.P. Ogle - for mkg

Division of General, Restora and Neurological Devices

Page 1 of 2

510(k) Number K080773

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K050773

## Traditional 510(k) Premarket Notification

#### Indications for Use (continued)

When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skelefally mature patients in the treatment of the following acute and chronic instabilities or deformities:

- 1) Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- 2) Trauma (i.e. Fracture or Dislocation)
- 3) Spinal Stenosis
- 4) Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
- 5) Tumors
- 6) Failed Previous Fusion