When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYSTM 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)
Spondvlolisthesis .
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) in treating thoracic conditions only. 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 OASYSTM System can also be linked to the Xia System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

Device Description

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of two rod-to-rod connectors (axial and parallel versions) used to link the 3.5mm OASYS™ System rods with the Xia® 4.5 Spinal System rods (510(k) numbers #K050461 and #K060361). The Xia® 4.5 Spinal System rods will retain their original cleared name.

AI/ML Overview

This document is a Special 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS™ System. It does not describe a study proving a device meets acceptance criteria in the traditional sense of a clinical or performance study with numerical targets. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on material composition and validated mechanical properties.

Therefore, the requested information elements related to clinical study design, ground truth, expert adjudication, sample sizes for test/training sets, and comparative effectiveness studies are not applicable in this context.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The primary "acceptance criterion" for this 510(k) is demonstrating equivalent mechanical properties to the predicate device.

Acceptance Criterion	Reported Device Performance
Equivalent mechanical properties to the predicate OASYS™ System (K032394)	"Testing has demonstrated that the additional rod-to-rod connector components have equivalent mechanical properties to the predicate OASYS™ System (K032394)."
Same indications for use as the predicate device	"Both the new components and the existing system components are intended to address the same indications for use."
Made from the same materials as the predicate device	"Both the new components and the existing components are made from the same materials."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a Special 510(k) submission for a line extension, not a clinical study involving human or animal subjects that would require a "test set" and associated data provenance in this manner. The "testing" mentioned refers to mechanical property validation on the device components themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. See point 2. The "ground truth" here is the established mechanical properties of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 2.

5. 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 submission is for spinal fixation components, not an AI or imaging device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for spinal fixation components, not an algorithm or software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established mechanical properties of the predicate device, as determined by engineering standards and testing, and the material composition of the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of device submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" in the context of this type of device submission. The "ground truth" for demonstrating substantial equivalence (as described in point 7) would have been established through engineering design, material specifications, and standardized mechanical testing processes.

Summary

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Image /page/0/Picture/2 description: The image shows a series of handwritten characters and numbers, followed by the words "Special 510(k) Premarket Notification". The handwritten sequence appears to be "K 6 2 8 S3" on the top line, with a "p" and "1" on the second line. The text below is printed in a smaller font and seems to be part of a document or form.

Special 510(k) Summary of Safety and Effectiveness: Line Extension to the OASYSTM System

Proprietary Name:	Stryker Spine OASYST™ System
Common Name:	Spinal Fixation Appliances	OCT 24 2006
Proposed Regulatory Class:	Class II
	21 CFR 888.3070 (b)(1): Pedicle Screw Spinal System,
	21 CFR 888.3050: Spinal Interlaminal Fixation
	Orthosis
Device Product Code:	87 MNI: Orthosis, Spinal, Pedicle Fixation
	87 KWP: Appliance, Fixation, Spinal Interlaminal
For Information contact:	Simona Voic
	Regulatory Affairs Project Manager
	2 Pearl CourtAllendale, NJ 07401
	Telephone: (201) 760-8145
	Fax: (201) 760-8345
	Email: Simona.Voic@stryker.com
Date Summary Prepared:	September 22, 2006

Stryker Spine OASYS™ System: K032394 & K052317 Predicate Device Identification

Predicate Device Description

The Stryker Spine OASYSTM System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. 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 Stryker Spine OASYS™ System can be linked to the Stryker Spine Xia® Spinal System and SR90D System via the rod-to-rod connectors.

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K 6 z 8 S 3
P 2 3
Special 510(k) Premarket Notification

Description of Device Modification

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: 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) in treating thoracic conditions only. 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.

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Statement of Technological Comparison:

Testing has demonstrated that the additional rod-to-rod connector components have equivalent mechanical properties to the predicate OASYS™ System (K032394). Both the new components and the existing system components are intended to address the same indications for use. Both the new components and the existing components are made from the same materials.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2006

Stryker Spine c/o Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K062853

Trade Name: Line Extension to the OASYS™ System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, KWP Dated: September 22, 2006 Received: September 25, 2006

Dear Ms. Voic:

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.

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

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Page 2 - Ms. Simona Voic

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Charbare Buchm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 4 6 6 2 8 5 3

Device Name: Line Extension to the QASYSTM System

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine OASYSTM 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)
Spondvlolisthesis .
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) in treating thoracic conditions only. 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 OASYSTM System can also be linked to the Xia System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

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 General, Restorative,
and Neurological Devices

Page1of1

510(k) Number K06 2853

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.