STRYKER SPINE OASYS SYSTEM

K032394 · Howmedica Osteonics Corp. · MNI · Feb 20, 2004 · Orthopedic

Device Facts

• Record ID: K032394
• Device Name: STRYKER SPINE OASYS SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MNI · Orthopedic
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• 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; and Tumors. When used with the occipital plate the bone screws are limited to occipital fixation. 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 Spinal System via the rod to rod connector.

Device Story

The Stryker Spine Oasys System is a posterior spinal fixation construct consisting of titanium alloy rods, polyaxial screws, bone screws, hooks, and occiput plates. Designed for surgical stabilization of the cervical and upper thoracic spine (C1-T3) to promote fusion. Components are implanted by surgeons in an operating room setting. The system provides mechanical stabilization of the spine following trauma, degenerative conditions, or revision surgery. It can be integrated with the Xia Spinal System using rod-to-rod connectors. The device provides structural support to the spinal column, facilitating bone fusion and potentially reducing pain and instability associated with spinal pathologies.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Constructed from titanium alloy. Components include rods, polyaxial screws, bone screws, hooks, and occiput plates. Non-sterile. Mechanical fixation system for spinal stabilization.

Indications for Use

Indicated for patients requiring cervical spine and occipito-cervico-thoracic (Occiput-T3) fusion due to degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, or tumors. Bone screws restricted to occipital fixation; polyaxial screws restricted to T1-T3 thoracic conditions.

Regulatory Classification

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.

Special Controls

*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.

Reference Devices

• Xia Spinal System

Submission Summary (Full Text)

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# FEB 2,0 2004

| Proprietary Name: | Stryker Spine Oasys System |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis<br>21 CFR 888.3050<br>Pedicle Screw Spinal System<br>21 CFR 888.3070 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 KWP: Appliance, Fixation, Spinal Interlaminal<br>87 MNI: Orthosis, Spinal, Pedicle Fixation |
| For Information contact: | Karen Ariemma<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | December 18, 2003 |

# 510(k) Summary for Stryker Spine Oasys System

### Device Description

The Stryker Spine Oasys 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. The components will be provided non-sterile.

## 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; and Tumors.

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When used with the occipital plate the bone screws are limited to occipital fixation. 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 Spinal System via the rod to rod connector.

# Substantial Equivalence

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed posterior occipito-cervico-thoracic spine systems. Mechanical testing demonstrated comparable mechanical properties to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

FEB 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Stryker Howmedica Osteonics 59 Route 17 Allendale, New Jersey 07401-1677

K032394 Re:

> Trade Name: Styker Spine OASYS System Regulation Number: 21 CFR 888.3050 Regulation Number: 21 CFR 888.3070 (b) (1), 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Product Code: MNI, KWP Dated: December 18, 2003 Received: December 19, 2003

Dear Ms. Ariemma:

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. Karen Arienima

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited of a substition with other requirements of the Act
that FDA has made a determination that your device are neepsies. You must that FDA has made a determination that your as a secures agencies. You must and or any Federal statutes and regulations and limited or registration and listing (21)
comply with all the Act's requirements, including, but not be registration and listing fo comply with all the Act s requirements, mendanty, varies requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFK Part 801); good manatating (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 200); and if app forth in the quality systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Scetions 35 d 12 cm device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a leval This letter will anow you to begin harketing your artial equivalence of your device to a legally premarket notification. The FDA imaling of substanted by 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
rs and the many of the many 2011650. Also aloca note the requilation entitl If you desire specific advice for your de nec on one of the regulation entitled, the regulation entitled, would be contact the Office of Complance at (301) 57 - 1007 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by reference to prematical reading the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-204 other general information on your responsibilities and to toll-free mumber [phone] or
Manufacturers, International and Consumer Assistance at its toll-ifremain html Manufacturers, International and Collisand Prosisons of Consumer of the Manufacturers (1

Sincerely yours,

Mark N Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

#### 510(k) Number (if known): Ko 3 2 3 9 4

#### Device Name: Stryker Spine Oasys System

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -13), the Stryker Spine Oasys System is intended for:

- Degenerative Disc Disease (as defined by ncck 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) in treating thoracic conditions only. They are not intended to be placed in the ccrvical 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 Spinal System via the rod to rod connector.

Mark N Millkur

Division of General. Restoralize. and Neurological Devices

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 03 259 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)