ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION

K062228 · Zimmer, Inc. · HAW · Nov 8, 2006 · Neurology

Device Facts

• Record ID: K062228
• Device Name: ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
• Applicant: Zimmer, Inc.
• Product Code: HAW · Neurology
• Decision Date: Nov 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip 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 or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures

Device Story

Manual orthopedic hip instruments; feature slots to accommodate Medtronic electromagnetic tracking sensors; enable digitized landmark (imageless) referencing for optical and electromagnetic tracking systems. Used in OR by surgeons; function as accessories to image-guided surgery systems. Instruments provide physical interface for tracking; system correlates rigid anatomical structures (long bones) with CT/MR models, fluoroscopy, or digitized landmarks. Assists surgeon in navigation during hip procedures; improves precision in bone/joint reconstruction and fracture repair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual orthopedic instruments; stainless steel/medical grade materials; integrated slots for Medtronic electromagnetic tracking sensors; compatible with optical and electromagnetic image guidance systems; non-powered; reusable; sterilized via standard hospital methods.

Indications for Use

Indicated for patients requiring hip orthopedic procedures where stereotaxic surgery is appropriate, including total/hemi-hip arthroplasty (primary/revision), minimally invasive hip procedures, tumor resection, bone/joint reconstruction, and stabilization/repair of pelvic/femoral fractures.

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 - Hip Instruments (K033223)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

NOV - 8 2006

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 31, 2006 |
| Trade Name: | Zimmer® Computer Assisted Solutions -<br>Electromagnetic and Imageless Hip Instrumentation |
| Common Name: | Image Guided Instrument |
| Classification Name<br>and Reference: | Stereotaxic Instrument<br>21 CFR § 882.4560 |
| Predicate Devices: | Zimmer Ortho Guidance Systems - Hip<br>Instruments, K033223, cleared February 18, 2004. |
| Device Description: | This submission is for: |
| | Zimmer orthopedic manual hip instruments that<br>each have a slot which accommodates a<br>Medtronic electromagnetic tracking sensor, andThe addition of digitized landmark (imageless)<br>referencing to the indications for use for both<br>optical and electromagnetic tracking sensors. |
| Intended Use: | Zimmer Hip Computer Assisted Solutions<br>Instruments are intended as accessories to Image<br>Guided Surgery systems and are indicated for any<br>hip 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<br>landmarks of the anatomy. Example orthopedic |

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procedures for these instruments include, but are not limited to:

- Total or Hemi-Hip Arthroplasty (Primary and . Revision)
- . Minimally Invasive Hip Orthopedic Procedures
- Tumor Resection and Bone/Joint Reconstruction .
- Stabilization of Repair of Pelvic/Femoral . Fractures

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 testing 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 this device.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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0023

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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 circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2006

Zimmer, Inc. % Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K062228

Trade/Device Name: Zimmer Ortho Guidance "Systems -- Hip Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 28, 2006 Received: December 12, 2006

Dear Ms. Jenks:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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

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### Page 2 - Ms. Patricia Jenks

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. 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/industry/support/index.html.

Sincerely vours.

For
Mark N. Melkerson

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

Kobozz8 510(k) Number (if known):

### Device Name:

Zimmer® Hip Computer Assisted Solutions - Electromagnetic and Imageless Instrumentation

### Indications for Use:

Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip 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 or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restoral ... and Neurological Devices

**510(k) Number** K041228

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