ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION

K052425 · Zimmer, Inc. · HAW · Dec 28, 2005 · Neurology

Device Facts

• Record ID: K052425
• Device Name: ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
• Applicant: Zimmer, Inc.
• Product Code: HAW · Neurology
• Decision Date: Dec 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Zimmer Knee Computer Assisted Solutions 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, fluoroscopy images, or digitized landmarks 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 Computer Assisted Solutions (CAS) knee instruments function as accessories to image-guided surgery systems. The device consists of manual orthopedic instruments modified with slots to accommodate Medtronic electromagnetic tracking sensors. It supports both optical and electromagnetic tracking, including digitized landmark (imageless) referencing. Used in OR settings by surgeons, the instruments allow for real-time tracking of rigid anatomical structures (long bones) relative to CT/MR models, fluoroscopy, or digitized landmarks. By providing spatial orientation during knee arthroplasty or minimally invasive procedures, the system assists surgeons in precise instrument positioning, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data was required or provided for this device. Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.

Technological Characteristics

Manual orthopedic instruments featuring slots for Medtronic electromagnetic tracking sensors. Supports optical and electromagnetic tracking modalities. Enables imageless referencing via digitized anatomical landmarks. Designed for use with existing image-guided surgery systems. No specific materials or software algorithm classes are detailed beyond the mechanical integration of tracking sensors.

Indications for Use

Indicated for patients requiring knee orthopedic procedures, including primary and revision total knee arthroplasty, unicompartmental knee arthroplasty, and minimally invasive knee procedures, where stereotaxic surgery 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

• Zimmer Ortho Guidance Systems - Knee Instruments (K033011)

Submission Summary (Full Text)

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## DEC 2 8 2005

## Summary of Safety and Effectiveness

# K052425

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey<br>Manager, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | September 1, 2005 |
| Trade Name: | Zimmer® Computer Assisted Solutions -<br>Electromagnetic and Imageless Knee<br>Instrumentation |
| Common Name: | Image Guided Instrument |
| Classification Name<br>and Reference: | Stereotaxic Instrument<br>21 CFR § 882.4560 |
| Predicate Device: | Zimmer Ortho Guidance Systems - Knee<br>Instruments, manufactured by Zimmer, Inc.,<br>K033011, cleared February 12, 2004. |
| Device Description: | This submission is for: |
| | • Zimmer orthopedic manual knee instruments<br>that have a slot that accommodates a Medtronic<br>electromagnetic tracking sensor, and<br>• The addition of digitized landmark (imageless)<br>referencing to the indications for use for both<br>optical and electromagnetic tracking sensors. |
| Intended Use: | Zimmer Knee Computer Assisted Solutions<br>Instruments are intended as accessories to Image<br>Guided Surgery systems and are indicated for any<br>knee orthopedic medical condition in which the use<br>of stereotaxic surgery may be appropriate, and<br>where reference to a rigid anatomical structure, such<br>as a long bone, can be identified relative to a CT or<br>MR based model, fluoroscopy images, or digitized |

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landmarks 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

Both the predicate and proposed devices are indicated for use with image guidance surgery systems. Both are accessory instruments.

Non-Clinical Performance and Conclusions:

Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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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 consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2005

Mr. Stephen H. McKelvey, MA, RAC Manager, Corporate Regulatory Affairs Zimmer, Inc. 345 East Main Street Warsaw, Indiana 46581-0708

Re: K052425

K032425
Trade/Device Name: Zimmer® Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 15, 2005 Received: December 19, 2005

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device t we nave reviewed your bection 910(x) proximatially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) to regary inate of the Medical Device Amendments, or to devices that prior to May 20, 1770, the onactions with the provisions of the Federal Food, Drug, and Cosmetic Italy bech recuired in accordinal of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mance mo device, sabject to an essent of annual registration, listing of devices, good controls provibitions or and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sublicitions. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 I DA mas muse a were mations 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 iaceming (DS) 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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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 promaticate 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/industry/support/index.html.

Sincerely yours,

Barbara Bouchard

Mark N. Melkerson Acting 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

KOSSHAS 510(k) Number (if known):

Device Name:

Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Knee Instrumentation

#### Indications for Use:

Zimmer Knee Computer Assisted Solutions 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, fluoroscopy images, or digitized landmarks 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

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)

5245 Barbara Buend
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K052425