ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS

K033223 · Zimmer, Inc. · HAW · Feb 18, 2004 · Neurology

Device Facts

• Record ID: K033223
• Device Name: ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
• Applicant: Zimmer, Inc.
• Product Code: HAW · Neurology
• Decision Date: Feb 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Zimmer Ortho Guidance Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic medical condition resulting from disease or trauma in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to: Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures

Device Story

Zimmer Ortho Guidance Hip Instruments are modified manual orthopaedic surgical instruments designed to interface with the Medtronic StealthStation Image Guidance System. Instruments feature physical modifications to accept Medtronic image guidance arrays. Used in clinical settings by surgeons during hip procedures; instruments provide spatial reference points to the navigation system. System correlates physical instrument position with pre-operative CT/MR models or intra-operative fluoroscopy. Output allows surgeons to visualize instrument trajectory relative to patient anatomy on navigation display; assists in precise placement of implants or hardware. Benefits include improved surgical accuracy and guidance during minimally invasive or complex reconstructive hip procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual orthopaedic instruments modified to accept Medtronic image guidance arrays. Designed for use with Medtronic StealthStation Image Guidance System. No electronic components, energy sources, or software algorithms contained within the instruments themselves.

Indications for Use

Indicated for patients with hip orthopaedic conditions (disease or trauma) requiring stereotaxic surgery where rigid anatomical structures (pelvis/long bone) can be referenced against CT, MR, or fluoroscopic images. Procedures include total/hemi-hip arthroplasty, tumor resection, bone/joint reconstruction, and pelvic/femoral fracture stabilization.

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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# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | October 3, 2003 |
| Trade Name: | Zimmer Ortho Guidance™ Systems – Hip<br>Instruments |
| Common Name: | Image Guided Instrument |
| Classification Name<br>and Reference: | Stereotaxic Instrument<br>21 CFR § 888.4560 |
| Predicate Device: | Catheter Introducer for the StealthStation System<br>manufactured by Medtronic Surgical Navigation<br>Technologies, K022126, cleared January 3, 2003. |
| Device Description: | The Zimmer Ortho Guidance Hip Instruments are<br>orthopaedic manual instruments modified to accept<br>a Medtronic Image Guidance System array and are<br>to be used with the Medtronic StealthStation®<br>System. |
| Intended Use: | Zimmer Ortho Guidance Hip Instruments can be<br>used as accessories to Image Guided Surgery<br>systems and are indicated for any hip orthopaedic<br>medical condition resulting from disease or trauma<br>in which the use of stereotaxic surgery may be<br>appropriate, and where reference to a rigid<br>anatomical structure, such as a long bone or pelvis,<br>can be identified relative to a CT or MR based<br>model or fluoroscopy images of the anatomy.<br>Example procedures for these instruments include,<br>but are not limited to: |

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Image /page/1/Picture/0 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside of a circle, followed by the word "Zimmer" in a simple, sans-serif font. The letter Z and the word "Zimmer" are both in black, while the circle is white with a black outline.

# Traditional 510(k) Premarket Notification

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

The proposed devices can be used as accessory instruments (like the predicate). Both predicate and proposed devices are indicated for use with Image Guidance Surgery Systems.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

No guidance documents exist for these instruments. 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 this devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K033223

Trade/Device Name: Zimmer Ortho Guidance™ Systems – Hip Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Codc: HAW Dated: December 11, 2003 Received: December 12, 2003

Dear Ms. Cain:

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 complics 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. Karen Cain

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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# Indications for Use

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

K033223

### Device Name:

Zimmer Ortho Guidance" Systems - Hip Instruments

#### Indications for Use:

Zimmer Ortho Guidance Systems Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic 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 or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to:

Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or 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)

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

Concellers Edit GDBH Agics of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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K033 22.3 510(k) Number