COLUMBUS REVISION KNEE SYSTEM

K083772 · Aesculap Implant System, Inc. · JWH · Jun 4, 2009 · Orthopedic

Device Facts

• Record ID: K083772
• Device Name: COLUMBUS REVISION KNEE SYSTEM
• Applicant: Aesculap Implant System, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Columbus Revision 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 Revision Knee System is designed to for use with bone cement.

Device Story

Cemented, fixed-bearing knee prosthesis system; intended for revision or primary reconstruction of diseased knee joints. System comprises femoral and tibial components in various sizes; femoral component features Posterior Stabilizing (PS) design for ligamentous instability. Manufactured from CoCrMo alloy with UHMWPE tibial gliding surfaces. Intended for surgical implantation by orthopedic surgeons in clinical/hospital settings. Device provides mechanical joint stabilization and articulation to restore function and alleviate pain in patients with arthritis or failed previous implants. Requires bone cement for fixation.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with FDA guidance for cemented, semi-constrained total knee prostheses and orthopedic device 510(k) requirements.

Technological Characteristics

Fixed-bearing, semi-constrained, cemented knee prosthesis. Materials: CoCrMo alloy (femoral/tibial components) and UHMWPE (tibial gliding surfaces). Single-use, sterile. Design includes Posterior Stabilizing (PS) femoral component.

Indications for Use

Indicated for patients requiring knee joint reconstruction due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or failed prior arthroplasties/osteotomies with persistent pain, deformity, or dysfunction. Includes patients with correctable valgus/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

• Aesculap Columbus Total Knee System CR/PS (K022672/K030367)
• Zimmer NexGen Complete Knee Solution Legacy Constrained Condylar Knee (K960279)

Submission Summary (Full Text)

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Columbus REVISION Knee System

K083772 #11

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#### B. 510(k) SUMMARY (as required by 21 CFR 807.92) Columbus Revision Knee System JUN - 4 2009 December 18, 2008 Aesculap Implant Systems®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311 CONTACT: Lisa M. Boyle 610-984-9274 (phone) 610-791-6882 (fax) TRADE NAME: REVISION COMMON NAME: Columbus Revision Knee System CLASSIFICATION NAME: Prosthesis, Knee, Patellofemorotibial, Semiconstrained, Cemented, Polymer/Metal/Polymer REGULATION NUMBER: 888.3560 PRODUCT CODE: JWH

# SUBSTANTIAL EQUIVALENCE

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

- . Aesculap's Columbus Total Knee System CR/PS (K022672/K030367),
- . Zimmer's NexGen Complete Knee Solution Legacy Constrained Condylar Knee (K960279)

# DEVICE DESCRIPTION

The cemented Columbus Revision Knee System is a fixed prosthesis system that is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization it the ligament (PCL) is absent, weakened, or sacrificed during implantation. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE. The complete system (femoral and tibial) makes up of numerous component available in various sizes. All components are sterile and for single use only.

# INDICATIONS FOR USE

The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, theumatoid 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 Revision Knee System is designed to for use with bone cement.

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K083772 Columbus REVISION Knee System

## TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The components of the Aesculap Implant Systems® Columbus Revision Knee System are offered in a similar range of shapes and sizes as the predicate devices. The material used for the Aesculap Implant Systems 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 for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-. Constrained Total Knee Prostheses", and
- "Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & . Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 an eagle or a stylized human figure with outstretched arms.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems, Inc. % Ms. Lisa Boyle 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K083772

Trade/Device Name: Columbus Revision 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: May 29, 2009 Received: June 2, 2009

Dear Ms. Lisa Boyle:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Cabane buempe

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### A. INDICATIONS FOR USE STATEMENT

510(k) Number: KD83772

## Device Name: Columbus REVISION Knee System

# Indications for Use:

The Columbus Revision 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 Revision Knee System is designed to for use with bone cement.

Prescription Use X and/or Over-the-Counter Use

(per 21 CFR 801.109)

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

Smita Dr.
(Division Sign)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083772