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 following reduction 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, SR90D 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 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® family and Xia 4.5 Systems and SR90D System.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA to Stryker Corporation regarding their OASYS® System for spinal interlaminal fixation. It is a clearance letter and a 510(k) summary, not a study evaluating device performance against acceptance criteria in the way a diagnostic AI device or software might be assessed.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided text. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and engineering analysis, rather than clinical performance metrics.

Specifically:

A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "engineering analysis" to show that new longer length transition rods do not affect performance, but does not provide specific acceptance criteria or performance metrics for the OASYS system itself.
Sample sized used for the test set and the data provenance: Not applicable. The "study" mentioned is an "engineering analysis," not a clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this type of submission is typically based on pre-established engineering standards and comparisons to predicate devices, not on expert consensus from a clinical test set.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a spinal fixation device, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used: For this type of device, the "ground truth" for substantial equivalence is derived from established mechanical and material properties, and comparison to the predicate device's design and performance.
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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June 9, 2015

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

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

Re: K150753

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: April 9, 2015 Received: April 10, 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

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

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely vours.

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) K150753

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 following reduction 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Corporation2 Pearl CourtAllendale, NJ 07401
Contact Person	Garry T. Hayeck, Ph.D.Senior Regulatory Affairs SpecialistPhone: 201-760-8043Fax: 201-760-8406E-mail: garry.hayeck@stryker.com
Date Prepared	March 20, 2015
Trade Name	OASYS® System
Common Name	Spinal Fixation Appliances
Proposed Class	Class II
Classification Name,Codification	Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050
Product Codes	KWP
Predicate Devices	Primary Predicate:Stryker Spine OASYS® System: K142741
Device Description	The Stryker Spine OASYS® System is comprised of rods, polyaxialscrews, bone screws, hooks, connectors, and occiput plates. Thecomponents are available in a variety of lengths in order toaccommodate patient anatomy. The components are fabricatedfrom Titanium alloy and CP Titanium and are provided non-sterile. Thesubject system also offers Vitallium® rods. The Stryker Spine OASYS®System can be linked to the Stryker Spine Xia® family and Xia 4.5Systems and SR90D System.
Indications for Use	When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine OasysSystem is intended for:• Degenerative Disc Disease (as defined by neck and back pain ofdiscogenic origin with degeneration of the disc confirmed by historyand radiographic studies)• Spondylolisthesis• Spinal Stenosis• Fracture/Dislocation• Atlanto/axial fracture with instability• Occipitocervical dislocation• Revision of previous cervical spine surgery• TumorsWhen used with the occipital plate, the bone screws are limited tooccipital fixation only. The bone screws are not intended to be used inthe cervical spine.The use of the polyaxial screws is limited to placement in the upperthoracic spine (T1 -T3). They are not intended to be placed in thecervical spine.
	The hooks and rods are also intended to provide stabilization topromote fusion following reduction of fracture/dislocation or trauma inthe cervical/upper thoracic (C1-T3) spine.
	The Stryker Spine OASYS® System can be linked to the Xia® System,SR90D System and Xia® 4.5 Spinal System via the rod-to-rodconnectors and transition rods.
	The Stryker Spine OASYS® System can also be linked to the polyaxialscrews of Xia® II and Xia® 3 System via the saddle connector.
Summary of	The subject OASYS® System shares the same materials, geometries,
Technological	and fundamental scientific technologies as predicate OASYS®
Characteristics	Systems. The proposed new transition rods are identical to previouslycleared OASYS® transition rods with the exception that thoracolumbarsection of the rod is longer in length.
Summary of	An engineering analysis was performed to demonstrate that the
Performance Data	addition of the longer length transition rods does not affect theperformance of the OASYS® System.
Conclusion	The devices, methodologies, and materials used in this system areequivalent to previously cleared OASYS® Systems. As such, thesubject system is substantially equivalent to previously clearedOASYS® Systems.

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Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.