COLUMBUS (CR) TOTAL KNEE SYSTEM

K023788 · Aesculap, Inc. · JWH · Dec 13, 2002 · Orthopedic

Device Facts

• Record ID: K023788
• Device Name: COLUMBUS (CR) TOTAL KNEE SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 13, 2002
• 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 intended 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 persists, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. The Columbus Knee is designed for use with bone cement.

Device Story

Cemented total knee prosthesis; femoral component and tibial tray manufactured from CoCrMo; UHMWPE inserts and patellas. Cruciate Retaining (CR) design preserves PCL; optional 'deep dish' insert provides increased stability with reduced range of motion. Intended for surgical implantation by orthopedic surgeons to replace diseased knee joints. Benefits include pain relief, restoration of joint function, and correction of deformities. Device relies on bone cement for fixation.

Clinical Evidence

Bench testing only. Biomechanical testing performed in accordance with FDA guidance for cemented, semi-constrained total knee prostheses.

Technological Characteristics

Materials: CoCrMo (femoral component, tibial tray), UHMWPE (inserts, patellas). Design: Cemented, semi-constrained, Cruciate Retaining (CR). Features: Standard and 'deep dish' insert options. Energy source: N/A (mechanical).

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. Also indicated for 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

• Search Evolution Total Knee System (K021313)
• Scorpio Posterior Cruciate Retaining Knee System (K974556)
• Gem Knee System (K994214)

Submission Summary (Full Text)

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Columbus Knee System Insert

# DEC 1 3 2002

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

### COLUMBUS (CR) TOTAL KNEE SYSTEM

November 10, 2002

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>joyce.kilroy @ aesculap.com (email) |
| TRADE NAME: | Columbus (CR) Total Knee System |
| COMMON NAME: | Total Knee System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | JWH |
| CLASSIFICATION: | 888.3560 |
| REVIEW PANEL: | Orthopedics |

### INTENDED USE

The Columbus (CR) Total Knee System is intended 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 persists, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee is designed for use with bone cement.

#### DEVICE DESCRIPTION

The cemented Columbus (CR) Total Knee System is available with one femoral design, the Cruciate Retaining (CR) which retains the ligament (PCL) during implantation. The design of the femoral component and tibial plateau (tray) are manufactured from CoCrMo. In addition to the standard insert design, a "deep dish" design is available for patients that may need more stability than the standard design. The "deep dish" insert has a slightly smaller range of motion to provide more restraint than the standard insert design. The gliding surfaces (inserts) and patellas are manufactured from UHMWPE.

#### PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses" were completed. Biomechanical testing results demonstrate that the Columbus (CR) Total Knee System is substantially equivalent to other knee systems currently on the market.

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K0237-88

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# SUBSTANTIAL EQUIVALENCE

Aesculap believes that the Columbus Total Knee System is substantially equivalent to:

- Search Evolution Total Knee System (K021313) .
- Scorpio Posterior Cruciate Retaining Knee System (K974556) .
- Gem Knee System (K994214) .

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporațe Boulevard Rockville MD 20850

DEC 13 2002

Ms. Joyce Kilroy Director of Regulatory Affairs/ Quality Assurance Aesculap®, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K023788

Trade/Device Name: Columbus (CR) Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 10, 2002 Received: November 13, 2002

Dear Ms. Kilroy:

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. Joyce Kilroy

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

Mark N. Milken

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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Special 510(k) Premarket Notification

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Columbus (CR) Total Knee System

#### Indication for Use:

The Columbus (CR) Total Knee System is intended 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 persists, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee is designed for use with bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mullenn

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

510(k) Number K023788
or Over-the-Counter Use

Prescription Use

(per 21 CFR 801.109)

(Optional Format 3-10-98)