DEPUY CAS HIP INSTRUMENTATION

K052178 · DePuy Orthopaedics, Inc. · HAW · Oct 21, 2005 · Neurology

Device Facts

• Record ID: K052178
• Device Name: DEPUY CAS HIP INSTRUMENTATION
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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 enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, where reference to a rigid anatomical structure, 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 CAS Hip Instrumentation enables intraoperative navigation during hip reconstructive surgery. System utilizes BrainLAB Ci hardware platform and VectorVision Hip software. Input: landmarks on patient bone surface acquired intraoperatively; tracked via flexible passive markers. System maps instruments/implants onto virtual 3D computer-generated image of patient anatomy (CT/MR based). Surgeon uses navigation to guide femoral and acetabular instrumentation/implants. Used in OR by surgeons to improve positioning accuracy during TJR, revision surgery, or tumor resection.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Stereotaxic surgical instrument system. Utilizes infrared passive marker tracking. Hardware: BrainLAB Ci platform. Software: VectorVision Hip. Connectivity: Integrated system for instrument/implant tracking. Registration: Landmarks acquired on bone surface mapped to CT/MR-based 3D models.

Indications for Use

Indicated for patients requiring orthopaedic hip surgery, including Total Joint Replacement (TJR), revision TJR, and tumor resection/reconstruction, where stereotaxic navigation relative to rigid anatomical structures and CT/MR models 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

• VectorVision Hip (K040368)
• Zimmer Ortho Guidance Systems – Hip Instruments (K033223)
• Smith & Nephew Image-Guided Surgical Instruments for Hip Applications (K033341)
• Image Guided Surgical Instruments for Hip Applications (K021798)

Submission Summary (Full Text)

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## 0C1 2 1 2005

# K052178 SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
|----------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randa Franklin<br>Sr. Regulatory Specialist |
| Trade Name: | DePuy CAS Hip Instrumentation |
| Common Name: | Computer Assisted Surgery (CAS) Hip<br>Instrumentation |
| Regulatory Classification: | 882.4560; Stereotaxic Instrument; Class II |
| Device Product Code: | HAW |
| Substantially Equivalent Device: | • K040368 VectorVision Hip |
| | • K033223 Zimmer Ortho Guidance Systems –<br>Hip Instruments |
| | • K033341 Smith & Nephew Image-Guided<br>Surgical Instruments for Hip Applications |
| | • K021798 Image Guided Surgical Instruments<br>for Hip Applications |

### Device Description and Intended Use:

DePuy CAS Hip Instruments are computer recognized by application specific VectorVision Hip software on Ci hardware platform, owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during orthopaedic hip surgery. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intraoperatively during surgery. BrainLAB designed the Ci hardware platform exclusively for DePuy. Instrument/implant data is tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and acetabular instrumentation and implants for the most accurate position.

#### Basis of Substantial Equivalence:

Computer Assisted Surgical Hip Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments by means of tracking patient anatomy through infrared passive markers imposed onto computer images.

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OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Randa Franklin Sr. Regulatory Specialist DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K052178

Trade/Device Name: DePuy CAS Hip Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: October 4, 2005 Received: October 5, 2005

Dear Mr. Franklin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o neve roviewed your 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 for ass stated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to commer of prior to 1125 2011 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- Randa Franklin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally premaince health a 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 other Ectoral 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,

farbine Buehns

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: DePuy CAS Hip Instrumentation

### Indications for Use:

Instruments are tracked by a passive marker sensor system that acquires landmarks of the instruments are trucked by a pacerro mouter hardware and software. This enables a bone surface when interrasod with bosition of instrumentation by a virtual 3-D computer surgeon to accurately navigato the position on on the perative hip reconstructive generated image for proclos bensted for any medical condition in which the use of procedures. The system'is indication for any where reference to a rigid anatomical structure, stereotaxe surgery may be approphato, antive 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

Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of of of

(Posted November 13, 2003)
*Jan Marie Buehler for Nixon*

Division of General, Restorative, and Neurological Devices

510(k) Number k052178