TRIATHLON PKR SYSTEM

K071881 · Howmedica Osteonics Corp. · HRY · Oct 9, 2007 · Orthopedic

Device Facts

• Record ID: K071881
• Device Name: TRIATHLON PKR SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRY · Orthopedic
• Decision Date: Oct 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis . Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau. These components are intended for implantation with bone cement.

Device Story

Triathlon® PKR System is a modular, single-use, semi-constrained unicondylar knee prosthesis; replaces medial or lateral femoral condyle regions. Designed for implantation with bone cement in the knee joint. Used by orthopedic surgeons in a clinical/surgical setting to treat disabling joint disease or failed prior procedures. Provides a mechanical alternative to tibial osteotomy or total knee replacement for patients with unicompartmental deficiencies. Benefits include restoration of joint function and pain relief.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular unicondylar knee prosthesis; metal/polymer construction; semi-constrained design; intended for cemented fixation. No specific material standards or software components described.

Indications for Use

Indicated for patients with moderately disabling knee joint disease due to painful osteoarthritis or post-traumatic arthritis; patients requiring revision of previous unsuccessful surgical procedures (with or without prior unicompartmental knee prosthesis); patients with unicompartmental osteoarthritis as an alternative to tibial osteotomy; and patients with poor bone stock or inadequate bone for other reconstructive techniques due to femoral condyle/tibial plateau deficiencies.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Triathlon® Knee System (K031729, K040267)
• X30 UHMWPE Tibial Inserts and Patellar Components (K051146 & K063423)
• EIUS® Unicompartmental Knee System (K992287 & K033769)
• SCR® Unicompartmental Knee Prosthesis (K896856 & K911373)
• UNIX™ Unicompartmental Knee System (K923011)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Triathlon® Knee System Line Extension

#### Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Vivian Kelly, Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone]

Date Summary Prepared:

#### Device Identification

Proprietary Name: Common Name: Classification Name and Reference:

Proposed Regulatory Class: Device Panel/Product Code: July 6, 2007

Triathlon® PKR System Knee Prosthesis Components Knee Joint, Femorotibial, Polymer/Metal, Semi-constrained, Cemented Prosthesis, 21 CFR §888.3530 Class II 87 HRY, Prosthesis, Knee, Femorotibial, semi-constrained, Cemented, Metal/Polymer

#### Description:

The Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.

### Indications for Use:

- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

### Substantial Equivalence:

The device is substantially equivalent to its predicates for femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analyses demonstrate that the components from these systems are compatible when used for femorotibial replacement. Examples of predicate knee systems include the Triathlon® Knee System (K031729, K040267) and X30 UHMWPE Tibial Inserts and Patellar Components (K051146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K911373) and the UNIX™ Unicompartmental Knee System (K923011.) Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2007

Howmedica Osteonics Corp. % Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

Re: K071881

Trade/Device Name: Triathlon PKR System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: July 6, 2007 Received: July 9, 2007

Dear Ms. Kelly:

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 mav 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

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### Page 2 - Ms. Vivian Kelly

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Ambare Bnehn

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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# Indications for Use

510(k) Number (if known): K071881

Device Name: Triathlon® PKR System

Indications for Use:

- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not ◆ involving, previous use of a unicompartmental knee prosthesis
- . As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Chau Buehly Nixon
Division Sign. Off

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**Division of General, Restorative**
**and Neurological Devices**

**510(k) Number** K071881

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