COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE

K053579 · Aesculap, Inc. · JWH · May 17, 2006 · Orthopedic

Device Facts

• Record ID: K053579
• Device Name: COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
• Applicant: Aesculap, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Columbus 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 is designed for use with bone cement.

Device Story

Ultra Congruent (UC) Tibial Insert; component of Columbus Total Knee System. Gliding surface made of UHMWPE; provides increased contact area for improved stability in flexion and extension. Heights range 10 mm to 20 mm; sizes T0/T0+ to T5. Used in orthopedic surgery for knee joint reconstruction; implanted by surgeons using bone cement. Device functions as a mechanical bearing surface to restore joint function and reduce pain in patients with degenerative or post-traumatic knee conditions.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance for orthopedic devices, including metallic surface modifications, plasma sprayed coatings, non-articulating modular components, and UHMWPE data requirements.

Technological Characteristics

Material: UHMWPE. Form factor: Tibial insert gliding surface, 10-20 mm height, T0-T5 sizes. Principle: Semiconstrained cemented prosthesis. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring knee joint reconstruction due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, failed previous arthroplasties or osteotomies, or those 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

• Columbus Total Knee System (K022672)
• Columbus Total Knee System (K023788)
• VKS Knee System (K022204)

Submission Summary (Full Text)

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

Image /page/0/Picture/3 description: The image shows the text "KOS3579" in a bold, handwritten-like font. Below this, the text "Columbus Total Knee System" and "Ultra Congruent Tibial Insert" are printed in a smaller, standard font. The text appears to be part of a label or document, possibly related to medical equipment or orthopedic implants.

MAY 17 . 5

| | Columbus Total Knee System<br>(Ultra Congruent Tibial Insert)<br>December 21, 2005 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
| CONTACT: | Matthew M. Hull<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Columbus Total Knee System Ultra Congruent (UC) Tibial<br>Insert |
| COMMON NAME: | Total Knee System Gliding Surface |
| CLASSIFICATION NAME: | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis |
| REGULATION NUMBER: | 888.3560 |
| PRODUCT CODE: | IWH |

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Ultra Congruent Tibial Insert for the Columbus Total Knee System is a line extension of the standard and deep dish tibial inserts that were cleared as components of Aesculap's Columbus Total Knee System (K022672 and K023788). It is also substantially equivalent to the ultra congruent inserts that were cleared for the VKS Knee System (K022204).

### DEVICE DESCRIPTION

The Ultra Congruent Tibial Insert is a gliding surface for the Columbus Total Knee System made from UHMWPE. The ultra congruent insert is designed with increased contact area that provides improved stability in flexion and extension. The Columbus UC gliding surfaces range in height from 10 mm to 20 mm and in size from T0/T0+ to T5

### INDICATIONS FOR USE

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The Columbus Total 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 Knee is designed for use with bone cement.

# orre03

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# TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The UC tibial inserts are offered in similar in shapes and sizes as the standard and deep dish predicate devices. The same biocompatible material is used for the all of the Aesculap inserts (UC, Std, and DD) plus the UC insert for the VKS System of the Aesculap UC insert has an increased surface area over the standard and the deep dish and an area similar to the VKS UC inserts.

# PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" will be donoawhere applicable. In addition testing will be completed as applicable per the following:

- "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"
- "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices"

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2006

Mr. Matthew M. Hull, RAC Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K053579

> Trade/Device Name: Columbus Total Knee System Ultra Congruent (UC) Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 09, 2006 Received: May 10, 2006

Dear Mr. Hull:

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 - Mr. Matthew M. Hull, RAC

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,

Hechublerner mo)

Mark N. Melkerson, M.S. 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

Columbus Total Knee System Ultra Congruent Tibial Insert

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#### INDICATIONS FOR USE STATEMENT A.

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ KOE2STA

# 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 | |
|----------------------|---|-----------------------------|--|
| (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)
(Division/Sign-Off)
Division of General, Restorative,
and Neurological Devices
K053579
510(k) Number002