STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000

K050615 · Stryker Instruments · HAW · Apr 21, 2005 · Neurology

Device Facts

• Record ID: K050615
• Device Name: STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
• Applicant: Stryker Instruments
• Product Code: HAW · Neurology
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker Navigation System - CT Based 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

System provides computer-assisted planning and intraoperative guidance for orthopedic surgery; utilizes wireless video-optical tracking to localize instruments and anatomy. Inputs include imported patient CT scans; system processes data to monitor joint kinematics pre-operatively, intraoperatively, and post-implantation. Configurable workflow supports user-specific surgical protocols for femoral and acetabular preparation. Operated by orthopedic surgeons and clinic staff in clinical settings. Output displayed via graphical interface to assist surgeons in precise positioning of implants and bony tissue; enhances surgical accuracy and provides kinematic assessment to potentially improve patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Wireless video-optical tracking system; computer-assisted navigation; CT-based image importation; configurable graphical user interface; supports orthopedic surgical workflows. Designed per QSR 21 CFR 820.

Indications for Use

Indicated for orthopedic surgeons and clinic staff performing Total Hip Arthroplasty (THA) (open or minimally invasive), orthopedic surgeries requiring precise positioning of instruments, implants, and bony tissue (hip and upper extremities), and revision surgeries.

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.

Predicate Devices

• Stryker Navigation - Hip Module (K022365)
• Stryker Navigation - Neuro Module (K993239)
• VectorVision Hip System (K010602)

Submission Summary (Full Text)

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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com

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APR 2 1 2005

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Instruments

# KOSOGIS

| 510(k) Summary | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
| Registration No.: | 1811755 |
| Trade Name: | Stryker Navigation System - CT Based Hip Module |
| Common Name: | Navigation System |
| Classification Name: | Stereotactic Instruments |
| Equivalent to: | K022365 Stryker Navigation - Hip Module<br>K993239 Stryker Navigation - Neuro Module<br>K010602 VectorVision Hip System |
| Device Description: | Stryker Navigation System - CT Based Hip Module<br>The CT Based Hip Module is part of the product series of the Stryker Navigation System. The system comprises a computer assisted hip implantation control and monitoring module based on a wireless video-optical tracking localization device for the use in total hip arthroplasty. The CT-Based Hip module will allow the importation of CT scans into the system. Unique to other hip navigators the Stryker system provides Surgeons with pre-operative, intraoperative and postimplantation assessments of the patient's joint kinematics. The system supports different surgical protocols. The order of femoral and acetabular preparation is configurable as well as other user specific settings. The user settings adjust the workflow and the graphical interface sequence in order to match the user habits. |
| Intended Use: | Stryker Navigation System - CT Based Hip Module<br>The Stryker Navigation System - CT Based 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 should be operated only by trained personnel such as orthopedic surgeons and clinic staff.<br><br>The Stryker Navigation System - CT Based Hip Module supports, but is not limited to the following surgical procedures<br>■ Any form of Total Hip Athroplasty (THA), e.g. open or minimal-invasive<br>■ Precisely position instruments, implants and bony tissue during orthopedic surgery, such as operations performed with Hip and bones in the upper extremities |

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#### Substantial Equivalence (SE) Rational:

The Stryker Navigation System - CT Based Hip Module are equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker and BrainLab.

Safety and Effectiveness:

The Stryker Navigation System - CT Based Hip Module do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - CT Based Hip Module are substantially equivalent to these existing devices. They will be designed and manufactured in accordance with Stryker Leibinger's and Stryker Instrument's Quality Management System covered by QSR 21CFR 820.

Submitted by:

Becky Ditty Regulatory Affairs Representative

Signature

Date submitted:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2005

Ms. Becky Ditty Regulatory Affairs Representative Stryker Instruments, Inc. 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K050615

Trade/Device Name: Stryker Navigation System-CT Based Hip Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 8, 2005 Received: March 10, 2005

Dear Ms. Ditty:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associous to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror co may 2011-12-11 accordance with the provisions of the Federal Food, Drug, de noes mat have been require approval of a premarket approval application (PMA). and Cosmetic rece (110.) that to novice, subject to the general controls provisions of the Act. The r ou may, incretere, mains of the Act include requirements for annual registration, listing of general controls proficituring 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 n may of back 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 I Dri has made a and regulations administered by other Federal agencies. You must or any I cacal statuated and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 607); adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Becky Ditty

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 11 you t 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/industry/support/index.html.

Sincerely yours,

11

Miriam C. Provost, Ph.D. Acting 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): K050615

## Device Name: Stryker Navigation System - CT Based Hip Module

### Intended Use:

The Stryker Navigation System - CT Based 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 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 or 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 .

Prescription Use X (per 21 CFR 801 Subpart D)

or

Over-The-Counter Use (per 21 CFR 801 Subpart C)

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

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