COLUMBUS (CR) TOTAL KNEE SYSTEM

K053390 · Aesculap, Inc. · JWH · Feb 6, 2006 · Orthopedic

Device Facts

• Record ID: K053390
• Device Name: COLUMBUS (CR) TOTAL KNEE SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. The Columbus Knee (CR) is designed for use with bone cement.

Device Story

The Columbus (CR) Total Knee System additions consist of a CRA/PSA tibial tray and hemispacers (wedges) used in total knee arthroplasty. These components are designed for use with existing Columbus (CR) or (PS) femoral components and inserts. The device is intended for surgical implantation by orthopedic surgeons in a hospital or clinical setting to reconstruct diseased knee joints. The components are manufactured from CoCrMo and are intended for use with bone cement. By providing structural support and replacing damaged joint surfaces, the system aims to alleviate pain and restore function in patients with severe knee pathology.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance for orthopedic devices, including evaluations for metallic plasma sprayed coatings, non-articulating modular components, and UHMPE materials.

Technological Characteristics

Materials: CoCrMo. Components: CRA/PSA tibial tray and hemispacers (wedges). Design: Semiconstrained cemented prosthesis. Connectivity: None. Software: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring knee joint reconstruction due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or revision of failed arthroplasties/osteotomies with persistent pain, deformity, or dysfunction. Includes patients with correctable valgus or varus deformity and moderate flexion contracture.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Columbus Total Knee System (K022672)
• Smith & Nephew revision knee system (K043440)
• PLUS Orthopedic's VKS/TC Plus revision knee (K032215)
• PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667)
• Howmedica Osteonics's Tibial Tray Screw Hole Plugs (K032479)

Submission Summary (Full Text)

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#### 510(k) SUMMARY (as required by 21 CFR 807.92) B.

FEB 6 2006

Columbus Total Knee CRA/PSA Tibial tray & w

## Columbus (CR) Total Knee System

December 1, 2005

| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Columbus (CR)Total Knee System |
| COMMON NAME: | Total Knee System |
| CLASSIFICATION NAME: | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |
| REGULATION NUMBER: | 888.3560 |
| PRODUCT CODE: | JWH |

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Columbus (CR)Total Knee System additions are substantially equivalent to Aesculap's Columbus Total Knee System (K022672), Smith & Nephew's revision knee system (K043440) and PLUS Orthopedic's VKS/TC Plus revision knee (K032215), PLUS Orthopedic's RT-Plus Solution and RT-Plus Modular Knee (K023667), and Howmedica Osteonics's Tibial Tray Screw Hole Plugs (K032479).

## DEVICE DESCRIPTION

The cemented Columbus (CR)Total Knee System additions include a CRA/PSA tibial tray and hemispacers, commonly known as wedges. The CRA/PSA tibial tray and wedges can be used with the existing femoral component, insert, patella and attachment mechanism of the Columbus (CR) Total Knee System cleared via K022672 or with the femoral component and insert of the Columbus (PS) Total Knee System cleared via K030367. The CRA/PSA tibial tray and wedges are manufactured from CoCrMo.

## INDICATIONS FOR USE

The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee (CR) is designed for use with bone cement.

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# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The CRA/PSA tibial tray and wedges are offered in similar in shapes and sizes as the predicate devices. The material used for the Aseculap device is the same as that used to manufacture the predicate devices.

# PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the

- "Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components", and
- "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices" was completed where applicable.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and location.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 6 2006

Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K053390

> Trade/Device Name: Columbus (CR) Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 12, 2006 Received: January 13, 2006

Dear Ms. Racosky:

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

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Page 2 – Ms. Kathy A. Racosky

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. 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 A. Milliken

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 STATEMENT A.

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Columbus (CR) Total Knee System

Indications for Use:

The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee (CR) is designed for use with bone cement.

| Prescription Use | X | and/or Over-the-Counter Use | |
|-----------------------------|------------------------|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 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)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K05 3390 |
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