MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY

K012380 · Stryker Leibinger · HAW · Dec 3, 2001 · Neurology

Device Facts

• Record ID: K012380
• Device Name: MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
• Applicant: Stryker Leibinger
• Product Code: HAW · Neurology
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images.

Device Story

Stryker Navigation System - Spine & Fluoroscopy Module provides intraoperative guidance for orthopedic surgery. System utilizes medical images and references to rigid anatomical structures (skull, vertebra) to track instruments. Used in OR by surgeons to assist in precise positioning of fixation devices. System transforms image data and spatial tracking inputs into visual guidance for the surgeon, facilitating navigation during open or percutaneous procedures. Benefits include improved surgical accuracy and planning capabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotaxic instrument (Product Code: HAW). System functions as an image-guided planning and intraoperative navigation platform. Relies on registration of rigid anatomical structures to medical images for spatial tracking.

Indications for Use

Indicated for surgical procedures including pedicle screw placement, navigation, and positioning of internal/external fixation devices during orthopedic surgery involving spinal structures, hip, upper/lower extremities, and long bones. Not indicated for total joint replacement.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 0 3 2001

Ms. Robin L. Rowe Regulatory Affairs Representative Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K012380

Trade/Device Name: Stryker Navigation System - Spine & Fluoroscopy Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 24, 2001 Received: July 26, 2001

Dear Ms. Rowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved your 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 for association 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.

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 that + Diederal 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.

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Page 2 - Ms. Robin L. Rowe

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

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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| 510(k) Number: | K012380 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Stryker Navigation System -Spine & Fluoroscopy Module |
| Intended Use: | The Stryker Navigation System is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure such as the skull, or vertebra, can be identified relative to medical images. |
| Indications for Use: | The Stryker Navigation System- Spine & Fluoroscopy Module supports, but is not limited to the following surgical procedures: <ul><li>Pedicle Screw Placement</li><li>Navigation</li><li>Precisely positioning instruments such as internal and external fixation devices during orthopedic surgery, to include operations performed with spinal structure, hip and bones in the upper and lower extremities and long bones.</li><li>This submission is not intended for total joint replacement procedures.</li></ul> |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The- Counter Use |
|----------------------|----|-----------------------|
| (Per 21 CFR 801.109) | | |

Susan Walker, MD

| (Division Sign-Off)<br>Division of General, Restorative<br>and Neurological Devices | (Optional Format 1-2-96) |
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| 510(k) Number | K012380 |
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