STRYKER NAVIGATION SYSTEM - HIP MODULE

K022365 · Stryker Instruments · HAW · Jan 22, 2003 · Neurology

Device Facts

• Record ID: K022365
• Device Name: STRYKER NAVIGATION SYSTEM - HIP MODULE
• Applicant: Stryker Instruments
• Product Code: HAW · Neurology
• Decision Date: Jan 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker Navigation System - Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

Device Story

Stryker Navigation System - Hip Module is an image-guided surgery system for orthopedic procedures. It provides planning and intraoperative guidance for open or percutaneous surgeries, including Total Hip Arthroplasty (THA) and revisions. The system tracks rigid anatomical structures (pelvis, femur) to assist surgeons in precisely positioning instruments, implants, and bony tissue. Used in the operating theater by orthopedic surgeons and trained clinic staff. The system displays real-time navigation data to the surgeon, facilitating accurate surgical execution and potentially improving implant placement and surgical outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Image-guided surgery system for orthopedic navigation. Utilizes tracking of rigid anatomical structures (pelvis, femur). Operates within the operating theater environment. Software-based guidance system.

Indications for Use

Indicated for patients undergoing orthopedic surgery, including Total Hip Arthroplasty (THA) and revisions, where computer-assisted guidance is appropriate. Requires identification of rigid anatomical structures (e.g., pelvis, femur). For use by trained orthopedic surgeons and clinic staff in the operating theater.

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.

Reference Devices

• Stryker image guided surgery systems
• Sofamor Danek image guided surgery systems
• BrainLab image guided surgery systems

Submission Summary (Full Text)

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Ko22365

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: STRYKER NAVIGATION - HIP MODULE

JAN 2 2 2003

### General Information

| Proprietary Name: | Stryker Navigation System - Hip<br>Module<br>HipTrac |
|--------------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Image Guided Surgery System |
| Classification Name(s): | Instrument, Stereotaxic |
| Classification Code(s): | 84HAW |
| Submitter: | Stryker Corporation<br>Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Kelli J. Bitterburg<br>Regulatory Affairs Associate<br>Phone: [phone] x4026<br>Fax: [phone] |
| Summary Preparation Date: | July 19, 2002 |

### Summary of Safety and Effectiveness:

The Stryker Navigation System – Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

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The Stryker Navigation System – Hip Module supports, but is not limited to the following surgical procedures

- Any form of Total Hip Athroplasty (THA), e.g. open of minimal-O invasive
- Precisely position instruments, implants and bony tissue during O orthopedic surgery, such as operations performed with Hip and bones in the upper extremities
- o Revisions

The Stryker Navigation System is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems being marketed by companies such as Stryker, Sofamor Danek, and BrainLab.

They Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System is substantially equivalent to these existing devices.

Kelli J. Bitterburg

Regulatory Affairs Associate

Dated: 7/19/02

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2003

Ms. Kelli Bitterburg Regulatory Affairs Associate Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K022365

Trade Name: Stryker Navigation System - Hip Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: October 25, 2002 Received: October 28, 2002

Dear Ms. Bitterburg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

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.

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Page 2 - Ms. Kelli Bitterburg

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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 (if known):

Device Name: Stryker Navigation System - Hip Module

### Intended Use:

The Stryker Navigation System - Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

#### Indications for Use:

The system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures

- Any form of Total Hip Athroplasty (THA), e.g. open of minimal-invasive ●
- Precisely position instruments, implants and bony tissue during orthopedic . surgery, such as operations performed with Hip and bones in the upper extremities
- Revisions .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

Muriam C. Provost (Optional Format 1-2-96)

or

ivision Sign-Off) Jivision of General, Restorative and Neurological Devices

Number K022 365