MODIFICATION TO OASYS SYSTEM

K072568 · Stryker Spine · KWP · Oct 5, 2007 · Orthopedic

Device Facts

• Record ID: K072568
• Device Name: MODIFICATION TO OASYS SYSTEM
• Applicant: Stryker Spine
• Product Code: KWP · Orthopedic
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine OASYSTM System is intended for - Degenerative Disc Disease (as defined by neck . and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis . - Spinal Stenosis . - Fracture/Dislocation . - Atlanto/axial fracture with instability . - Occipitocervical dislocation . - Revision of previous cervical spine surgery . - . Tumors When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine. The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine. The Stryker Spine OASYS™ System™ can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.

Device Story

The OASYS™ System is a spinal fixation assembly consisting of polyaxial screws, hooks, and rods used by surgeons to stabilize the cervical and upper thoracic spine (C1-T3) to promote fusion. This line extension introduces new non-biased and cancellous polyaxial screw styles. The device is implanted during spinal surgery; it provides mechanical stabilization to the vertebral column. The system can be linked to other Stryker spinal systems (Xia®, SR90D) via rod-to-rod connectors. The surgeon uses the hardware to fixate bony segments, facilitating fusion in patients with instability or degenerative conditions. The device benefits patients by restoring spinal alignment and stability.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Spinal fixation system components including polyaxial screws, hooks, and rods. Materials are identical to the predicate OASYS™ System. Mechanical fixation principle. Designed for surgical implantation in the cervical and upper thoracic spine.

Indications for Use

Indicated for patients requiring spinal fusion in the cervical spine and occipito-cervico-thoracic junction (Occiput-T3) due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, or tumors. Polyaxial screws are restricted to T1-T3 thoracic use only; occipital plates are restricted to occipital fixation only. Not for use in the cervical spine for these specific screw types.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Stryker Spine's OASYST™ System (K032394, K052317, K062853)
• DePuy Spine, Inc. Summit OCT Spinal System (K030103, K041203)

Reference Devices

• Xia® System
• SR90D System
• Xia® 4.5 Spinal System

Submission Summary (Full Text)

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**OCT** 5 " 2007

Line Extension to the Stryker Spine OASYS™ System

Special 510(k) Premarket Notification

072568

## Special 510(k) Summary: Line Extension to the Stryker Spine OASYSTM System

| Proprietary Name: | OASYST™ System |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II<br>21 CFR 888.3070 (b)(1): Pedicle Screw Spinal Syster<br>21 CFR 888.3050: Spinal Interlaminal Fixation<br>Orthosis |
| Device Product Code: | MNI: Orthosis, Spinal Pedicle Fixation<br>KWP: Appliance, Fixation, Spinal Interlaminal |
| For Information contact: | Simona Voic<br>Regulatory Affairs Project Manager<br>2 Pearl Court<br>Allendale, NJ 07401<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | September 11, 2007 |
| Predicate Devices | Stryker Spine's OASYST™ System - 510(k)#:<br>K032394, K052317, & K062853<br>DePuy Spine, Inc. Summit OCT Spinal System -<br>510(k)#: K030103 & K041203 |

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Intended Use

Special 510(k) Premarket Notification

This 510(k) adds new polyaxial screw components Description of Device Modification (non-biased and cancellous styles) to the existing OASYSTM System.

> When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine OASYSTM System is intended for

- Degenerative Disc Disease (as defined by neck . and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation .
- Atlanto/axial fracture with instability .
- Occipitocervical dislocation .
- Revision of previous cervical spine surgery .
- . Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper

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#### Line Extension to the Stryker Spine OASYS™ System

Special 510(k) Premarket Notification

thoracic (C1 -T3) spine.

The Stryker Spine OASYS™ System™ can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.

Summary of the Technological Characteristics

The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 5 2007

Re: K072568

> Trade/Device Name: OASYS™ System Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: KWP. MNI Dated: September 11, 2007 Received: September 12, 2007

Dear Ms. Voic:

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. 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

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### Page 2 - Ms. Simona Voic

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,

Barbara Buchno

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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Line Extension to the Stryker Spine OASYSTM System

Special 510(k) Premarket Notification

# Indications for Use

K0725b8 510(k) Number (if known):

Device Name: Line Extension to the Stryker Spine OASYSTM System

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the Stryker Spine OASYSTM System is intended for:

- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Spinal Stenosis
- Fracture/Dislocation
- Atlanto/axial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The Stryker Spine OASYS™ System™ can also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

harbare Buchm

Division of Gener and Neurological Devices

**510(k) Number** K072568