MODIFICATION TO: OASYS SYSTEM

K101183 · Stryker Spine · KWP · Nov 9, 2010 · Orthopedic

Device Facts

• Record ID: K101183
• Device Name: MODIFICATION TO: OASYS SYSTEM
• Applicant: Stryker Spine
• Product Code: KWP · Orthopedic
• Decision Date: Nov 9, 2010
• 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 OASYS® System is intended for: Degenerative Disc Disease (as defined by neck or 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; Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and 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). 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 and polyaxial screws of Xia® II and Xia® 3 Systems via the saddle connector.

Device Story

The Stryker Spine OASYS® System is a spinal fixation orthosis consisting of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. This submission introduces a saddle connector as a line extension. The system is used by surgeons in clinical settings to stabilize the cervical and upper thoracic spine (C1-T3) to promote fusion. Components are fabricated from Titanium alloy, CP Titanium, and Vitallium®. The device provides mechanical stabilization following trauma or degenerative conditions. It is designed to be linked with other Stryker systems (Xia®, SR90D) to accommodate complex spinal constructs. The surgeon selects components based on patient anatomy to achieve fixation. The device benefits patients by providing structural support to the spine, facilitating fusion, and correcting instability or deformity.

Clinical Evidence

Bench testing only. Static and dynamic compression bending and torsion testing were performed in accordance with ASTM F 1717 to demonstrate mechanical equivalence to the predicate system.

Technological Characteristics

Materials: Titanium alloy, CP Titanium, Vitallium®. Components: Rods, polyaxial screws, bone screws, hooks, connectors, occiput plates. Connectivity: Linkable to Xia® and SR90D systems via rod-to-rod and saddle connectors. Mechanical testing: ASTM F 1717 (static/dynamic compression bending and torsion). Non-sterile.

Indications for Use

Indicated for patients requiring cervical spine or occipito-cervico-thoracic (Occiput-T3) fusion due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, pseudoarthrosis, or tumors. Bone screws restricted to occipital fixation; polyaxial screws restricted to T1-T3 thoracic spine.

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 OASYS® System (K032394, K052317, K062853, K072568, K080143, K093670)

Reference Devices

• Stryker Spine Xia® System
• Xia® 4.5 Spinal System
• SR90D System
• Xia® II System
• Xia® 3 System

Submission Summary (Full Text)

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Special 510(k) Premarket Notification

### Special 510(k) Summary Line Extension to the OASYS® System

NOV - 9 2010

| Proprietary Name: | Stryker Spine OASYST™ System |
|----------------------------|--------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II |
| | 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis |
| Device Product Code: | 87 KWP: Appliance, Fixation, Spinal Interlaminal |
| For Information contact: | Curtis D. Truesdale |
| | Regulatory Affairs Project Manager |
| | 2 Pearl Court |
| | Allendale, NJ 07401 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Summary Prepared: | November 4, 2010 |

#### Stryker Spine OASYS® System: K032394, K052317, Predicate Device Identification K062853, K072568. K080143, K093670

### Predicate Device Description

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® Spinal System, Xia 4.5 System and SR90D System.

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#### Description of Device Modification

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of the addition of the saddle connector.

## Intended Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYS® System is intended for: Degenerative Disc Disease (as defined by neck or 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; Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and 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). 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 and polyaxial screws of Xia® II and Xia® 3 Systems via the saddle connector.

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K101182

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### Statement of Technological Comparison:

Documentation is provided which demonstrates that the new component of the Stryker Spine Oasys System to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending testing, Dynamic Compression Bending testing, Static Torsion testing and Dynamic Torsion testing per ASTM F 1717 were conducted on the Oasys System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

NOV - 9 2010

Re: K101183

Trade/Device Name: Line Extension to the Stryker Spine OASYS® System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: October 13, 2010 Received: October 14, 2010

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, Orve 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Curtis D. Truesdale

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Buehrs
Sgt.

Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K101183

2010

Device Name: Line Extension to the Stryker Spine OASYS® System

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys 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)
- t 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 (TI-T3). They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization 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 and Xia® 4.5 Spinal System.

The Stryker Spine OASYS® System can also be linked to the Xia® System, SR90D System and Xia® 4.5 System via the rod-to-rod connectors and polyaxial screws of Xia® 11 and Xia® 3 Systems via the saddle connector.

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)

(Division Sign=Off) Division of Surgical, Orthopedic, and Restorative Devices

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