DEPUY CAS KNEE INSTRUMENTATION

K043223 · DePuy Orthopaedics, Inc. · HAW · Mar 4, 2005 · Neurology

Device Facts

• Record ID: K043223
• Device Name: DEPUY CAS KNEE INSTRUMENTATION
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Mar 4, 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 on the bone surface interfaced with computer hardware and software. This enables a surgeon to use a virtual 3D computer image for precise bone cuts during minimally invasive orthopaedic knee reconstructive procedures. The instrumentation system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure and may be appropriate, and where relative to a CT or MR based model of the anatomy.

Device Story

DePuy CAS Knee Instruments function as part of a computer-assisted surgical navigation system. The system utilizes flexible passive markers attached to surgical instruments and bone landmarks; these are tracked by an infrared sensor system. Inputs consist of spatial data from these markers and virtual 3D computer models of the patient's anatomy. The system processes this data to provide real-time navigation, allowing the surgeon to visualize instrument position relative to the patient's bone on a computer display. Used in the OR by orthopedic surgeons during minimally invasive knee procedures, the system assists in guiding femoral and tibial cutting guides and implant placement. By providing precise spatial feedback, the device aims to improve the accuracy of bone cuts and implant positioning, potentially leading to better surgical outcomes for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotaxic surgical instrument system; utilizes infrared tracking of passive markers; integrates with computer hardware/software for 3D visualization; compatible with CT or MR-based anatomical models; intended for minimally invasive orthopedic procedures.

Indications for Use

Indicated for patients undergoing orthopaedic knee reconstructive procedures, including total knee replacement, unicondylar knee replacement, ligament balancing, range of motion analysis, cruciate ligament surgery, and patella tracking, where stereotaxic navigation relative to rigid anatomical structures 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 CT-Free Knee (K021306)
• Acumen Surgical Navigation System (K031337)
• Zimmer Ortho Guidance System Knee Instruments (K033011)

Submission Summary (Full Text)

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MAR 3 - 2035

#### KO43223 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 Knee Instrumentation |
| Common Name: | Computer Assisted Surgery (CAS) Knee<br>Instrumentation |
| Regulatory Classification: | 882.4560; Stereotaxic Instrument; Class II |
| Device Product Code: | HAW |
| Substantially Equivalent Device: | K021306<br>• K021306 VectorVision CT-Free Knee |
| | •K031337 Acumen Surgical Navigation<br>System |
| | • K033011 Zimmer Ortho Guidance System<br>Knee Instruments |

## Device Description and Intended Use:

DePuy CAS Knee Instruments are computer recognized by application specific Ci TKR/UKR, VectorVision CT-Free Knee and VectorVision Knee hardware/software owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery. BrainLAB designed the Ci System exclusive to DePuy specific instrument/implant data 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 tibial cutting guides and implants for the most accurate position.

### Basis of Substantial Equivalence:

Computer Assisted Surgical Knee Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments that are tracked through infrared tracking passive markers imposed onto computer images.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 3 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Randa Franklin Senior Regulatory Specialist DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K043223

R043E25
Trade/Device Name: DePuy CAS Knee Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 4, 2005 Reccived: February 7, 2005

Dear Ms. Franklin:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premaince insubstantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced anove and nave determined the acres to the devices marketed in interstate for use stated in the enclosure) to regally mancede profits in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food. Dr commerce prior to May 28, 1970, the enactinent and economisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of any instit devices that have been reciassified in accordance with the previously of the Act (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . This and Cosment Act (Act) that do not require approvate as a seperal controls provisions of the Act. The You may, inerelore, market the devices, belyer to the g
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Feet merator required in the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (sec above) no existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EUA may be subject to such additional controller antiblions, Title 21, Parts 800 to 898. In addition. FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to be found in the Code of Peachar Inneerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not member Please be advised that FDA s issuance of a backanna.
that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a determination that your and your Federal agencies. You must of any Federal statutes and regulations annuality, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moraans, and managements as setting the counter CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Randa Franklin

This letter will allow you to begin marketing your device as described in your Section 5 [0(k) I his letter will anow you to begin manceing your are of your dever to a legally premarket nother in the PDA midning of backence of the since 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 If you desire specific advice for your do not our car .. Also, please note the regulation entitled, Contact the Office of Complance at (210) = i & a = = = = 807.97). You may obtain "Misbranding by reference to premailer nothlied.com the Division of Small .
other general information on your responsibilities under the Act from the 2000 . (200) . (200) other gelleral information on your response Assistance at its toll-free number [phone] or Malluracturers, Internet and Octisa http://www.fda.gov/cdrh/industry/support/index.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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Image /page/3/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle on the left, followed by the word "DePuy" in a bold, sans-serif font. A horizontal line is present under the word "DePuy". Below the line, the words "a Johnson & Johnson company" are written in a smaller, serif font.

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: DePuy CAS Knee Instruments

Indications for Use:

Instruments are tracked by a passive marker sensor system that acquires instruments are tracked by a passere interfaced with computer hardware and landmants on the bone camargeon to accurately navigate the position of sollware. This enables a surgeon to usearch mage for precise bone cuts Instrumentation by a virtual o D comparentive knee reconstructive procedures. The duning minimally invasive intrasperation in which the use of stereotaxic surgery system is mulcated for any moulour somalism in a rigid anatomical structure, such as a a
may be appropriate, and where reference to a rigid anatomical structure and may may be approphate, and where reative to a CT or MR based model of the anatomy.

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

- •Total Knee Replacement
- •Unicondylar Knee Replacement
- ·Ligament Balancing
- ·Range of Motion Analysis
- ·Cruciate Ligament Surgery
- ·Patella Tracking

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Prescription Use (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 ¨

OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Winning (Division Sign-Off

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Division of General Restorative. and Neurological Devices

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**510(k) Number** K043223