ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS

K033011 · Zimmer, Inc. · HAW · Feb 12, 2004 · Neurology

Device Facts

• Record ID: K033011
• Device Name: ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
• Applicant: Zimmer, Inc.
• Product Code: HAW · Neurology
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty (Primary and Revision) Minimally Invasive Knee Orthopedic Procedures

Device Story

Zimmer Ortho Guidance Systems - Knee Instruments are manual orthopedic surgical instruments modified to interface with the Medtronic StealthStation Image Guidance System (IGS). The instruments are equipped to accept an IGS array, allowing the surgeon to track the position of the instrument relative to patient anatomy (long bones) during surgery. The system utilizes pre-operative or intra-operative imaging (CT, MR, or fluoroscopy) to provide spatial guidance. Used in clinical settings by surgeons for knee arthroplasty and minimally invasive procedures, the device assists in precise instrument positioning. The output is visual guidance provided by the Medtronic StealthStation, which aids the surgeon in clinical decision-making regarding bone resection and implant placement, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data was required or provided for this submission. Bench testing was not performed; the manufacturer committed to conducting QSR validation and verification for the instruments in conjunction with the Medtronic StealthStation system.

Technological Characteristics

Manual orthopedic surgical instruments modified to include an interface for Medtronic Image Guidance System (IGS) arrays. The system relies on external optical or electromagnetic tracking provided by the Medtronic StealthStation. No internal energy source or software; the device is a mechanical accessory.

Indications for Use

Indicated for patients requiring knee orthopedic procedures, including primary/revision total knee arthroplasty, primary/revision unicompartmental knee arthroplasty, and minimally invasive knee procedures, where stereotaxic surgery and anatomical reference to long bones via CT, MR, or fluoroscopy is appropriate.

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

• Catheter Introducer for the StealthStation System (K022126)

Submission Summary (Full Text)

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Ko33011

Image /page/0/Picture/1 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside a circle, followed by the word "zimmer" in a bold, sans-serif font. The letter Z is black, and the word "zimmer" is also black.

## Traditional 510(k) Premarket Notification

# FEB 1 2 2004

## Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen McKelvey<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | September 25, 2003 |
| Trade Name: | Zimmer Ortho Guidance Systems - Knee<br>Instruments |
| Common Name: | Image Guided Instrument |
| Classification Name<br>and Reference: | Stercotaxic Instrument<br>21 CFR § 882.4560 |
| Predicate Device: | Catheter Introducer for the StealthStation System,<br>manufactured by Medtronic Surgical Navigation<br>Technologies, K022126, cleared January 3, 2003. |
| Device Description: | This submission is for Zimmer orthopedic manual<br>knee instruments modified to accept an Medtronic<br>Image Guidance System (IGS) array and to be used<br>with the Medtronic StealthStation® System |
| Intended Use: | Zimmer Knee Ortho Guidance Instruments are<br>intended as accessories to Image Guided Surgery<br>systems and are indicated for any knee orthopedic<br>medical condition in which the use of stereotaxic<br>surgery may be appropriate, and where reference to<br>a rigid anatomical structure, such as a long bone,<br>can be identified relative to a CT or MR based<br>model or fluoroscopy images of the anatomy.<br>Example orthopedic procedures for these<br>instruments include, but are not limited to: |

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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.

#### Traditional 510(k) Premarket Notification

- ﺖ Total Knee Arthroplasty (Primary and Revision)
- -Unicompartmental Knee Arthroplasty (Primary and Revision)
- Minimally Invasive Knee Orthopedic -Procedures

Both the predicate and proposed devices are indicated for use with Image Guidance Surgery systems. Both are accessory instruments.

Non-Clinical Performance and Conclusions:

No testing was needed for these devices. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2004

Mr. Stephen H. McKclvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K033011

Trade/Device Name: Zimmer Ortho Guidance Systems - Knee Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 10, 2003 Received: December 11, 2003

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 gencral 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 madc 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 - Mr. Stephen II. McKelvey

This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promatted 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/dsma/dsmamain.html

Sincerely yours,

C. 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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#### Indications for Use

## 510(k) Number (if known):

#### Device Name:

Zimmer Ortho Guidance Systems - Knee Instruments

#### Indications for Use:

Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the Burgery systems and are may be appropriate, and where reference to a rigid anatomical use of stereoumn's a long bone, can be identified relative to a CT or MR based model or Straters of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knce Arthroplasty (Primary and Revision) Minimally Invasive Knec Orthopedic Procedures

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative. and Neurological Devices

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**510(k) Number** K033011