COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY

K071499 · Aesculap Implant Systems, Inc. · JWH · Sep 14, 2007 · Orthopedic

Device Facts

• Record ID: K071499
• Device Name: COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Traditional
• 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 is designed for use with bone cement.

Device Story

Columbus MIOS CR/PS tibial tray is a sterile, single-use orthopedic implant component. It functions as part of the Columbus Total Knee System, integrating with previously cleared femoral components, inserts, and patellar components. The device is intended for cemented fixation in the knee joint. It is used by orthopedic surgeons in a clinical/surgical setting to address joint disease, deformity, or failed prior surgeries. The tray features a PMMA Nano-Bond surface pretreatment on CoCrMo alloy to facilitate bone cement interface. By replacing or resurfacing damaged joint surfaces, the system aims to reduce pain, correct deformity, and restore joint function for the patient.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance for orthopedic implants, including evaluations for modified metallic surfaces, plasma sprayed coatings, non-articulating modular components, and UHMPE data requirements.

Technological Characteristics

CoCrMo alloy tibial tray with PMMA Nano-Bond surface pretreatment. Designed for cemented application. Semi-constrained prosthesis. Dimensions and shapes are consistent with predicate devices. No software or electronic components.

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)
• Howmedica Osteonics Scorpio Low Profile Tibial Tray (K032829)
• Zimmer's Millar/Galante Precoated Total Knee (K853661)

Submission Summary (Full Text)

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SEP 1 4 2007

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### Columbus Total Knee System MIOS CR/PS Tibial Tray

K071499

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

| Columbus (CR) Total Knee System<br>(MIOS CR/PS Tibial Tray)<br>May 31, 2007 | |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| COMPANY: | Aesculap Implant Systems Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Columbus Total Knee System MIOS CR/PS Tibial<br>Tray |
| 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 Implant Systems Inc. believes that the Columbus Total Knee System MIOS CR/PS Tibial Tray is substantially equivalent to Aesculap Implant Systems Inc. Columbus Total Knee System (K022672), Howmedica Osteonics Scorpio J ow Profile Tibial Tray (K032829), and Zimmer's Millar/Galante Precoated Total Knee (K853661).

## DEVICE DESCRIPTION

The Columbus MIOS CR/PS tibial tray is a sterile, single-use device that is intended to be used with the previously cleared femoral component, insert, patella, and attachned to mechanism of the Columbus (CR) Total Knee System or with the femoral component and insert of the Columbus (PS) 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, theumatoid arthritis, post-traumation of this, 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 MIOS CR/PS tibial tray is offered in similar shapes and sizes as the predicate devices. The base material used for the Aseculap Implant Systems device is the same as that used to manufacture the predicate devices. The only difference is a PMMA Nano-Bond surface pretreatment to the CoCrMo implants. The materials used in the PMMA Nano-Bond surface pretreatment are commonly used on other medical 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 is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

SEP 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems Inc. % Ms. Kathy A. Racosky Regulatory Affairs Specialist 3773Corporate Parkway Center Valley, PA 18034

Re: K071499

Trade/Device Name: Columbus Total Knee System MIOS CR/PS Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: August 20, 2007 Received: August 21, 2007

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 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. Kathy A. Racosky

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Barbara Buchus

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:

## 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 is designed for use with bone cement.

X Prescription Use

(per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -- Goneurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) Nun