COLUMBUS (PS)

K030367 · Aesculap, Inc. · JWH · Aug 21, 2003 · Orthopedic

Device Facts

• Record ID: K030367
• Device Name: COLUMBUS (PS)
• Applicant: Aesculap, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Columbus Total Knee System (PS) 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. Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The Columbus Knee (PS) is designed for use with bone cement.

Device Story

Columbus Total Knee System (PS) is a cemented, semi-constrained knee prosthesis. System comprises femoral component, tibial plateau (tray), tibial gliding surface inserts, and patella. Femoral and tibial components are CoCrMo; inserts and patellas are UHMWPE. Device is implanted by orthopedic surgeons in a clinical/surgical setting to reconstruct diseased knee joints. Posterior Stabilized design provides mechanical stability for patients with absent or compromised posterior cruciate ligaments. System requires bone cement for fixation. Clinical benefit includes restoration of joint function, pain relief, and correction of deformity.

Clinical Evidence

Bench testing only. Biomechanical testing performed in accordance with 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses' to demonstrate substantial equivalence.

Technological Characteristics

Cemented, semi-constrained knee prosthesis. Materials: CoCrMo (femoral component, tibial tray), UHMWPE (tibial inserts, patella). Design: Posterior Stabilized (PS). Fixation: Bone cement. Class II device (21 CFR 888.3560).

Indications for Use

Indicated for patients with diseased knee joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or failed prior arthroplasties/osteotomies; patients with correctable valgus/varus deformity and moderate flexion contracture. Posterior Stabilized components indicated for absent/non-functioning posterior cruciate ligament and severe anteroposterior knee instability.

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 PS Knee System (K962152)
• Scorpio Total Stabilizer (K0994128)
• Gem Knee System (K994214)
• Gem PS Total Knee System (K010101)

Submission Summary (Full Text)

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Columbus Total Knee System

**AUG 21 2003**

K030367

Page 1 of 2

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

## Columbus Total Knee System (PS)

February 4, 2003

- Aesculap(8), Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
Establishment Registration Number: 2916714

- Joyce Kilroy CONTACT: 800/258-1946 x 5074 (phone) 610/791-6882 (fax)
- TRADE NAME: Columbus (PS)

COMMON NAME: Columbus Total Knee System (PS)

DEVICE CLASS: Class II

PRODUCT CODE: 87 JWH

CLASSIFICATION: 888.3560 - Prosthesis, Knee, Patellofemortibial Semi-constrained, Cemented, polymer/metal/polymer

- REVIEW PANEL: Orthopedics
### INDICATIONS FOR USE

The Columbus Total Knee System (PS) 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.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

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

### DEVICE DESCRIPTION

The cemented Columbus Knee System (PS) is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization if the ligament (PCL) is absent, weakened or sacrificed during implantation. The design of the femoral component, and tibial plateau (tray) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.

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Columbus Total Knee System

#### PERFORMANCE DATA

KO 30367 page 1 of 2

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 the Columbus Knee System is substantially equivalent to other knee systems currently on the market.

### SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Columbus Total Knee System is substantially equivalent to:

- Search Evolution Total Knee System (K021313) .
- Scorpio PS Knee System (K962152) .
- Scorpio Total Stabilizer (K0994128) .
- Gem Knee System (K994214) ●
- Gem PS Total Knee System (K010101) .

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

# AUG 21 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joyce Kilroy Director of Regulatory Affairs and Quality Assurance Aesculap Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K030367

Trade/Device Name: Columbus Total Knee System (PS) Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 4, 2003 Received: June 5, 2003

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 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. Joyce Kilroy

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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Milkerson

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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#### INDICATIONS FOR USE STATEMENT B.

Page 1 of 1

K030367 510(k) Number:

Device Name: Columbus Total Knee System (PS)

Indication for Use:

The Columbus Total Knee System (PS) 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.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The Columbus Knee (PS) is designed to 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)

(Division Sign-Off) Division of General Restorative and Neuror Ja Ca

510(k) Number K03036

Prescription Use

or Over-the-Counter Use

(per 21 CFR 801.109)