OASYS System

K142741 · Stryker Corporation · KWP · Jan 15, 2015 · Orthopedic

Device Facts

• Record ID: K142741
• Device Name: OASYS System
• Applicant: Stryker Corporation
• Product Code: KWP · Orthopedic
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Traditional
• 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 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 ). They are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. The Stryker Spine OASYS® System can be linked to the Xia® System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods. The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.

Device Story

Spinal fixation system; includes rods, polyaxial screws, bone screws, hooks, connectors, occipital plates. Used by surgeons in clinical settings to stabilize cervical/upper thoracic spine (C1-T3) to promote fusion. Components implanted to provide mechanical support for degenerative conditions, trauma, or tumors. System links to other Stryker spinal systems (Xia family, SR90D) via connectors. Provides structural stabilization; aids patient recovery by maintaining alignment during bone healing.

Clinical Evidence

Bench testing only. Engineering analysis performed to demonstrate that the addition of screws with a modified drive mechanism does not affect the performance of the OASYS® System.

Technological Characteristics

Components fabricated from Titanium alloy and CP Titanium; Vitallium® rods available. System includes rods, polyaxial screws, bone screws, hooks, connectors, and occipital plates. Non-sterile. Mechanical fixation via screw/hook/rod assembly. Square drive mechanism on modified screws.

Indications for Use

Indicated for patients requiring cervical/upper thoracic (C1-T3) spinal fusion due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision surgery, or tumors. Contraindicated for use of bone screws in cervical spine (occipital only) and polyaxial screws in cervical spine (upper thoracic T1-T3 only).

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 (K111719)

Reference Devices

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

Submission Summary (Full Text)

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January 15, 2015

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

Stryker Corporation % Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K142741

Trade/Device Name: OASYS® System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 19, 2014 Received: December 22, 2014

Dear Dr. Hayeck:

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. 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 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

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Page 2 - Garry T. Hayeck, Ph.D.

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K142741

Device Name OASYS® System

Indications for Use (Describe)

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)

- · 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 ). They are not intended to be placed in the cervical spine.

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

The Stryker Spine OASYS® System can be linked to the Xia® System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.

The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary: OASYS® System | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 |
| Contact Person | Garry T. Hayeck, Ph.D.<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | December 16, 2014 |
| Trade Name | OASYS® System |
| Common Name | Spinal Fixation Appliances |
| Proposed Class | Class II |
| Classification Name,<br>Codification | Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 |
| Product Codes | KWP |
| Predicate Devices | Primary Predicate Device:<br>Stryker Spine OASYS® System: K111719 |
| Device Description | The Stryker Spine OASYS® System is comprised of rods, polyaxial<br>screws, bone screws, hooks, connectors, and occiput plates. The<br>components are available in a variety of lengths in order to<br>accommodate patient anatomy. The components are fabricated<br>from Titanium alloy and CP Titanium and are provided non-sterile. The<br>subject system also offers Vitallium® rods. The Stryker Spine OASYS®<br>System can be linked to the Stryker Spine Xia® family and Xia 4.5<br>Systems and SR90D System. |
| Indications for Use | When intended to promote fusion of the cervical spine and occipito-<br>cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys<br>System is intended for:<br>Degenerative Disc Disease (as defined by neck and back pain of<br>discogenic origin with degeneration of the disc confirmed by history<br>and radiographic studies)SpondylolisthesisSpinal StenosisFracture/DislocationAtlanto/axial fracture with instabilityOccipitocervical dislocationRevision of previous cervical spine surgeryTumors<br>When used with the occipital plate, the bone screws are limited to<br>occipital fixation only. The bone screws are not intended to be used in<br>the cervical spine.<br><br>The use of the polyaxial screws is limited to placement in the upper<br>thoracic spine (T1 -T3). They are not intended to be placed in the<br>cervical spine. |
| | The hooks and rods are also intended to provide stabilization to<br>promote fusion following reduction of fracture/dislocation or trauma in<br>the cervical/upper thoracic (C1-T3) spine. |
| | The Stryker Spine OASYS® System can be linked to the Xia® System,<br>SR90D System and Xia® 4.5 Spinal System via the rod-to-rod<br>connectors and transition rods. |
| | The Stryker Spine OASYS® System can also be linked to the polyaxial<br>screws of Xia® II and Xia® 3 System via the saddle connector. |
| Summary of<br>Technological<br>Characteristics | The subject OASYS® System shares the same materials, geometries,<br>and fundamental scientific technologies as predicate OASYS®<br>Systems. The proposed new screws are identical to previously cleared<br>OASYS® screws with the exception that they incorporate a square<br>drive mechanism. |
| Summary of<br>Performance Data | An engineering analysis was performed to demonstrate that the<br>addition of screws with a modified drive mechanism does not affect<br>the performance of the OASYS® System. |
| Conclusion | The devices, methodologies, and materials used in this system are<br>equivalent to previously cleared OASYS® Systems. As such, this system<br>is substantially equivalent to the legally marketed predicate devices. |

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