The Stryker Spine OASYS® System is intended to provide immobilization and stabilization 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, 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 the Xia® II and Xia® 3 Systems 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

The provided document is a 510(k) summary for the Stryker Corporation's OASYS® System, a medical device for spinal fixation. It details the device's indications for use and a summary of its technological characteristics. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for an AI/CADe device.

Instead, this 510(k) submission is related to establishing substantial equivalence between the current OASYS® System and previously cleared predicate devices (K150539 and K150753). The "Summary of Performance Data" section explicitly states:

"This submission seeks to reconcile the expansion of indications cleared under K150539 with the new implants cleared under K150753. Therefore, no additional performance data is necessary."

This indicates that the submission is focused on regulatory alignment and modifications to existing, cleared devices rather than providing new performance data from a prospective study to demonstrate effectiveness against specific acceptance criteria for a new or novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies from this document. This kind of information is typically found in the "Performance Data" or "Clinical Studies" sections of a 510(k) summary when a new device or significant modification requires such evaluations to demonstrate substantial equivalence.

Summary

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

July 9, 2015

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

Re: K151755

Trade/Device Name: OASYS® System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: June 26, 2015 Received: June 29, 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 (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 yours,

Lori A. Wiggins -S

for 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)

K151755

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 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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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: 201-962-4043E-mail: garry.hayeck@stryker.com
Date Prepared	June 26, 2015
Trade Name	OASYS® System
Common Name	Spinal Fixation Appliances
Proposed Class	Unclassified, Class II
Classification Name,Codification	Orthosis, Cervical Pedicle Screw Spinal FixationSpinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050
Product Codes	NKG, KWP
Predicate Devices	Primary Predicate:Stryker Spine OASYS® System: K150539Additional Predicate:Stryker Spine OASYS® System: K150753
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	The Stryker Spine OASYS® System is intended to provide immobilizationand stabilization of spinal segments as an adjunct to fusion for thefollowing acute and chronic instabilities of the craniocervical junction,the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumaticspinal fractures and/or traumatic dislocations; instability or deformity;failed previous fusions (e.g. pseudoarthrosis); tumors involving thecervical/thoracic spine; and degenerative disease, includingintractable radiculopathy and/or myelopathy, neck and/or arm painof discogenic origin as confirmed by radiographic studies, anddegenerative disease of the facets with instability.The Stryker Spine OASYS® System is also intended to restore theintegrity of the spinal column even in the absence of fusion for alimited time period in patients with advanced stage tumors involvingthe cervical spine in whom life expectancy is of insufficient duration topermit achievement of fusion.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
	The Stryker Spine OASYS® System can also be linked to the polyaxialscrews of the Xia® II and Xia® 3 Systems via the saddle connector.
Summary ofTechnologicalCharacteristics	The subject OASYS® System shares the same materials, geometries,and fundamental scientific technologies as the predicate OASYS®System. None of the aforementioned characteristics have beenaltered, augmented, or otherwise changed.
Summary ofPerformance Data	This submission seeks to reconcile the expansion of indications clearedunder K150539 with the new implants cleared under K150753.Therefore, no additional performance data is necessary.
Conclusion	The devices, methodologies, and materials used in this system areequivalent to previously cleared OASYS® Systems. As such, this systemis substantially equivalent to the predicate systems.

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Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
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.(b)
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.