OASYS System

K150539 · Stryker Corporation · NKG · May 12, 2015 · Orthopedic

Device Facts

• Record ID: K150539
• Device Name: OASYS System
• Applicant: Stryker Corporation
• Product Code: NKG · Orthopedic
• Decision Date: May 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine OASYS® System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. 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 Xia® II and Xia® 3 Systems via the saddle connector.

Device Story

OASYS® System is a spinal fixation construct consisting of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. Used by surgeons in clinical settings to provide spinal immobilization and stabilization. Components are implanted to support the cervical and thoracic spine; can be linked to other Stryker systems (Xia, SR90D) via connectors. Device provides mechanical support to the spinal column; aids in fusion or maintains structural integrity in tumor cases. Benefits include stabilization of unstable spinal segments and pain relief from degenerative conditions. System is non-sterile and requires surgical implantation.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717 and F1798, including static/dynamic compression bending and static/dynamic torsion, to demonstrate equivalence. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy, CP Titanium, and Vitallium®. Components: rods, polyaxial screws, bone screws, hooks, connectors, occiput plates. Mechanical testing per ASTM F1717 and F1798. Non-sterile. Standalone mechanical fixation system.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization as an adjunct to fusion. Conditions include traumatic fractures/dislocations, instability/deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors where fusion is not feasible due to limited life expectancy.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• Synthes Synapse Occipital-Cervical-Thoracic (OCT) System (K142838)
• Medtronic Vertex Reconstruction System (K143471)

Reference Devices

• Stryker Spine OASYS® System (K142741)

Submission Summary (Full Text)

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

May 12, 2015

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

Re: K150539

Trade/Device Name: OASYS® System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 2, 2015 Received: March 3, 2015

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 (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.

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

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) K150539

Device Name OASYS® System

### Indications for Use (Describe)

The Stryker Spine OASYS® System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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 Xia® II and Xia® 3 Systems via the saddle connector.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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### FOR FDA USE ONLY

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

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| 510(k) Summary: OASYS® System | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Stryker Corporation<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 | May 11, 2015 |
| Trade Name | OASYS® System |
| Common Name | Spinal Fixation Appliances |
| Proposed Class | Unclassified, Class II |
| Classification Name,<br>Codification | Orthosis, Cervical Pedicle Screw Spinal Fixation<br>Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 |
| Product Codes | NKG, KWP |
| Predicate/Referenced<br>Devices | Primary Predicate:<br>Synthes Synapse Occipital-Cervical-Thoracic (OCT) System: K142838<br><br>Additional Predicate:<br>Medtronic Vertex Reconstruction System: K143471<br><br>Reference Device:<br>Stryker Spine OASYS® System: K142741 |
| 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.<br><br>The purpose of this submission is to expand the use of the OASYS®<br>System to include the use of screws in the posterior cervical spine. |
| Indications for Use | The Stryker Spine OASYS® System is intended to provide immobilization<br>and stabilization of spinal segments as an adjunct to fusion for the<br>following acute and chronic instabilities of the craniocervical junction,<br>the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic<br>spinal fractures and/or traumatic dislocations; instability or deformity;<br>failed previous fusions (e.g. pseudoarthrosis); tumors involving the<br>cervical/thoracic spine; and degenerative disease, including<br>intractable radiculopathy and/or myelopathy, neck and/or arm pain<br>of discogenic origin as confirmed by radiographic studies, and<br>degenerative disease of the facets with instability.<br><br>The Stryker Spine OASYS® System is also intended to restore the<br>integrity of the spinal column even in the absence of fusion for a |
| | the cervical spine in whom life expectancy is of insufficient duration to<br>permit achievement of fusion. |
| | 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 the Xia® II and Xia® 3 Systems 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 the predicate devices.<br>None of the aforementioned characteristics have been altered,<br>augmented, or otherwise changed. |
| Summary of<br>Performance Data | Published literature and mechanical testing per ASTM F1717 & F1798<br>(static/dynamic compression bending; static/dynamic torsion) dem-<br>onstrate the OASYS® System is substantially equivalent. |
| Conclusion | The devices, methodologies, and materials used in this system are<br>equivalent to previously cleared predicate/reference devices. As<br>such, this system is substantially equivalent to the predicate systems. |

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