TRIATHLON TOTAL KNEE SYSTEM

K053514 · Stryker Orthopaedics · JWH · Jan 26, 2006 · Orthopedic

Device Facts

• Record ID: K053514
• Device Name: TRIATHLON TOTAL KNEE SYSTEM
• Applicant: Stryker Orthopaedics
• Product Code: JWH · Orthopedic
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General Total Knee Arthroplasty (TKA) Indications - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - Revision of previous unsuccessful uni-knee replacement or other procedure. Additional Indications for Universal Baseplates and Stem Components: - Ligamentous instability requiring implant bearing surface geometries with increased constraint. - Absent or non-functioning posterior cruciate ligament. Indications for Bone Augments: - Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. - Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied by bone loss. The Triathlon® Total Knee System components are intended for cemented use only.

Device Story

Triathlon® Total Knee System is a semi-constrained cemented knee prosthesis; replaces damaged knee joint surfaces. Used by orthopedic surgeons in hospital settings for total knee arthroplasty. System includes femoral, tibial, and patellar components, universal baseplates, stem components, and bone augments. Device restores joint configuration, function, and stability in patients with arthritis or deformity. Clinical benefit includes pain relief and improved mobility. Components are fixed to bone using cement.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Semi-constrained cemented prosthesis; materials include metal and polymer components. Designed for patellofemorotibial replacement. No software or electronic components.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of function, or moderate deformity (varus, valgus, flexion) requiring stabilization. Also indicated for revision of failed knee procedures, ligamentous instability, absent posterior cruciate ligament, and cases involving bone loss. Intended for cemented use only.

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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Ms. Tiffani D. Rogers Specialist, Regulatory Affairs Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K053514

Trade/Device Name: Triathlon® Total Knee System 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: December 15, 2005 Received: December 16, 2005

Dear Ms. Rogers:

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. Iisting 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

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#### Page 2 - Ms. Rogers

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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" (21 CFR 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/cdrl/industry/support/index.html.

Sincerely vours.

Houbara Buchum

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

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:PGA:rrr: 1/25/06

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# 510(k) Number (if known): K0535/4

Device Name: Triathlon® Total Knee System

## Indications for Use

General Total Knee Arthroplasty (TKA) Indications

- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid ● arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned ● to adequate function and stability.
- . Revision of previous unsuccessful uni-knee replacement or other procedure.

## Additional Indications for Universal Baseplates and Stem Components:

- Ligamentous instability requiring implant bearing surface geometries with increased constraint. ●
- Absent or non-functioning posterior cruciate ligament. .

## Indications for Bone Augments:

- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid � arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied . by bone loss.

The Triathlon® Total Knee System components are intended for cemented use only.

X 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)

barbarc Bucum

storative. and Neurological I

**510(k) Number** K053514