DEPUY CI HIP INSTRUMENTATION

K071135 · DePuy Orthopaedics, Inc. · HAW · May 23, 2007 · Neurology

Device Facts

• Record ID: K071135
• Device Name: DEPUY CI HIP INSTRUMENTATION
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HAW · Neurology
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The DePuy Ci Hip Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone preparation during intraoperative total hip replacement (THR) procedures. The system is indicated for total hip replacement procedures 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 of the anatomy. Example orthopaedic procedures for these instruments include, but are not limited to: Total Joint Replacement (TJR) Revision Surgery of TJR Tumor resection and Bone/Joint Reconstruction

Device Story

DePuy Ci Hip Instruments are reusable manual orthopaedic surgical instruments modified with navigation adapters; used with BrainLAB VectorVision Hip software and hardware. System utilizes passive marker sensor technology; marble-sized optical spheres attached to reference arrays track instrument position. Inputs include bone surface landmarks acquired intraoperatively; system transforms inputs into virtual 3-D computer-generated images. Used in OR by surgeons for precise bone preparation during hip procedures. Output provides real-time navigation of instrumentation relative to patient anatomy; assists surgeon in accurate positioning and bone resection. Benefits include improved surgical precision and anatomical alignment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, technological characteristics, and intended use comparisons.

Technological Characteristics

Reusable manual orthopaedic instruments; passive marker sensor system using optical spheres and reference arrays. Interfaces with computer hardware/software for 3-D navigation. Sterilization required. Software-based navigation platform.

Indications for Use

Indicated for patients undergoing total hip replacement (THR), total joint replacement (TJR), revision surgery of TJR, or tumor resection and bone/joint reconstruction where stereotaxic surgery is appropriate and rigid anatomical structures (e.g., long bones) can be referenced to CT or MR-based models.

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

• DePuy CAS Hip Instrumentation (K052178)
• BrainLAB VectorVision Hip Software (K05221)

Submission Summary (Full Text)

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# 1071135

## 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Natalie S. Heck<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | April 20, 2007 |
| PROPRIETARY NAME: | DePuy Ci ™ Hip Instrumentation |
| COMMON NAME: | Computer Assisted Surgery Instruments |
| CLASSIFICATION: | Class II per 21 CFR 882.4560, Stereotaxic<br>Instrument |
| DEVICE PRODUCT CODE: | 84 HAW |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy CAS Hip Instrumentation, K052178<br>BrainLAB VectorVision Hip Software, K05221 |

#### DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Ci ™ Hip Instruments are reusable manual orthopaedic surgical instruments modified with a navigation adapter for use with BrainLAB's VectorVision Hip version software on the DePuy Ci hardware platform.

These instruments are designed for either manual or computer navigation use. The BrainLAB Starlock arrays and marble-sized optical spheres enable the instruments to interface with computer assisted imaging hardware and software. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intra-operatively during surgery.

Instruments are tracked by marble sized marker spheres attached to a reference array creating a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. A virtual 3-D computer image is

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generated enabling a surgeon to accurately navigate the position of instrumentation for precise bone preparation during intraoperative hip surgery.

### INDICATIONS FOR USE:

The DePuy Ci Hip Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrument tion by a virtual 3-D computer generated image for precise bone preparation during intraoperative total hip replacement (THR) procedures. The system is indicated for total hip replacement procedures 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 of the anatomy.

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

- . Total Joint Replacement (TJR)
- . Revision Surgery of TJR
- Tumor resection and Bone/Joint Reconstruction .

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject DePuy Ci Hip Instrumentation is substantially equivalent to the existing DePuy CAS Hip Instrumentation (K052178), based on the similarities in design, intended use, materials, sterility, and use of computer navigation, and does not raise new issues of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Natalie S. Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

MAY 2 3 2007

Re: K071135

Trade/Device Name: DePuy Ci" Hip Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 20, 2007 Received: April 23, 2007

Dear Ms. Heck:

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 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. Natalie S. Heck

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 yours,

Mark N. Melkerson son
Director

Division of General, Restorativ
and Neurological Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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## Indications for Use Statement

510 (k) Number (if known):

DePuy Ci ™ Hip Instrumentation Device Name:

#### Indications for Use:

Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This condics a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer a generated image for precise bone preparation during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in vhich the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomic of structure, such as a long bone, can be identified relative to a CT or MR hased model of the anatomy.

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

- Total Joint Replacement (TJR)
- Revision Surgery of TJR .
- Tumor resection and Bone/Joint Reconstruction

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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)

(Division Sign-Off)

(Posted November 13, 2003) Division of General, Restorative, Page 1 of 1
and Neurological Devices

| 510(k) Number | k 071135 |
|---------------|----------|
|---------------|----------|