TRIATHLON METAL BACKED PATELLA

K061521 · Howmedica Osteonics Corp. · MBH · Aug 11, 2006 · Orthopedic

Device Facts

• Record ID: K061521
• Device Name: TRIATHLON METAL BACKED PATELLA
• Applicant: Howmedica Osteonics Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The metal backed patella is intended for patellar resurfacing to alleviate pain, instability and the restriction of motion.

Device Story

Triathlon Metal Backed Patella is a prosthetic component for total knee arthroplasty; designed for patellar resurfacing to alleviate pain and restore motion. Device features a porous-coated metal back with a preassembled polyethylene anterior surface; available in four sizes to fit resected patella. Used by orthopedic surgeons in clinical settings; intended for cementless fixation. Device provides a mechanical interface to replace damaged patellar surfaces; benefits patients by restoring joint function and reducing pain associated with degenerative or traumatic joint conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metal-backed patellar component with porous-coated metal backing and preassembled polyethylene anterior surface. Designed for cementless fixation. Available in four sizes. Class II device under 21 CFR 888.3565.

Indications for Use

Indicated for total knee arthroplasty to relieve pain and restore function in patients with noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis, functional deformity, post-traumatic loss of joint anatomy (patello-femoral erosion, dysfunction, prior patellectomy), or irreparable knee fracture. Intended for cementless fixation.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Duracon metalbacked patella (K032418)

Submission Summary (Full Text)

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Kouszl (pg 1 of 2)

AUG 1 1 2006

# 510(k) Summary of Safety and Effectiveness for the Triathlon® Metal Backed Patella

Proprietary Name:

Triathlon Metal Backed Patella

Common Name:

Classification Name and Reference

Total Knee Joint Replacement Prosthesis

Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated; Uncemented prosthesis 21 CFR §888.3565

Regulatory Class:

Device Product Code:

For Information contact:

Class II

87 MBH - prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.

Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: [phone] Fax: [phone] E-Mail: [e-mail]

Date Summary Prepared:

June 1, 2006

#### Device Description

The Triathlon® Metal Backed Patella is designed to offer patellar resurfacing when needed with the Duracon® or Triathlon® Total Knee Systems. The subject metal-backed patella is available in four sizes designed to fit the peripheral shape of the resected patella. The posterior surface of the patella features a porous coated metal back, with a preassembled polyethylene anterior surface.

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# Intended Use:

The metal backed patella is intended for patellar resurfacing to alleviate pain, instability and the restriction of motion.

## Indications for Use

•

The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or . avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; .
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. .

These products are intended to achieve fixation without the use of bone cement.

## Substantial Equivalence:

The metal-backed patella is substantially equivalent to Howmedica Osteonics' Duracon metalbacked patella cleared in K032418. Each device is similar in design, and has the same indications, intended use, and sterilization.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

Howmedica Osteonics Corp. % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07432

Re: K061521

Trade/Device Name: Triathlon® Metal Backed Patella Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: June 1, 2006 Received: July 12, 2006

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f na re reviews 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 arior 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 nat (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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA

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# Page 2 - Ms. Tiffani Rogers

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 if you a 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,

Barbara Buchner

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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510(k) Number (if known):

Device Name:

## Indications for Use

The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or . avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- . Revision procedures where other treatments or devices have failed;
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. .

These products are intended to achieve fixation without the use of bone cement.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (Per 21 CFR 801.109)

Over-the-Counter Use

(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

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