MODIFICATION TO TRIATHLON TS KNEE SYSTEM

K072221 · Howmedica Osteonics Corp. · JWH · Oct 15, 2007 · Orthopedic

Device Facts

• Record ID: K072221
• Device Name: MODIFICATION TO TRIATHLON TS KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Triathlon TS Total Knee System tibial components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All tibial components presented in this submission are provided sterile for single-use.

Device Story

Triathlon TS Total Knee System is a semi-constrained, cemented knee prosthesis for primary or revision total knee arthroplasty. Device components include tibial inserts (sizes 1-8, 9-31mm thickness) featuring an open cam box with a tibial post slot to accommodate a cobalt chrome tibial post for increased stability. Inserts utilize a metal locking wire for assembly into previously cleared Triathlon tibial baseplates. Available in sequentially crosslinked or standard polyethylene. Used by orthopedic surgeons in clinical/OR settings to alleviate pain and restore knee function in patients with severe joint disease or instability. Provides mechanical stability to the knee joint through increased constraint geometries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semi-constrained, cemented patellofemorotibial prosthesis. Materials: Cobalt chrome (tibial post), polyethylene (sequentially crosslinked or standard). Design: Open cam box with tibial post slot, metal locking wire for baseplate assembly. Sterilization: Provided sterile for single-use.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis); post-traumatic loss of joint function; moderate varus, valgus, or flexion deformity; revision of unsuccessful knee replacement; or distal femur/proximal tibia fractures. Additional indications for PS/TS components include ligamentous instability, absent/non-functioning posterior cruciate ligament, and severe anteroposterior instability. TS components specifically indicated for severe instability secondary to compromised collateral ligament integrity. 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).

Predicate Devices

• Triathlon TS Total Knee System (K070095)

Submission Summary (Full Text)

{0}------------------------------------------------

007 1 5 2007

Howmedica
OSTEONICS

325 Corporate Drive Mahwah, NJ USA 07430

# 510(k) Summary of Safety and Effectiveness for the Triathlon® TS Knee System

| Proprietary Name: | Triathlon® TS Knee System |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Name and Reference | Joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis.<br>21 CFR §888.3560 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 JWH - prosthesis, knee, patellofemorotibial,<br>semi-constrained, cemented,<br>polymer/metal/polymer |
| For Information contact: | Tiffani Rogers<br>Regulatory Affairs Specialist<br>Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, New Jersey 07432<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Summary Prepared: | August 8, 2007 |

# Device Description

The Triathlon TS Total Knee System features TS and TS Plus tibial inserts available in sizes 1 through 8 and thicknesses from 9mm to 31mm. These tibial inserts used with the Triathlon TS Total Knee System have been modified. The tibial inserts feature an open cam box with a tibial post slot to accommodate a cobalt chrome tibial post intended for additional stability in the knee joint. The Triathlon TS tibial inserts also feature a metal locking wire for assembly into

{1}------------------------------------------------

previously cleared Triathlon tibial baseplates. The Triathlon TS Plus and the Triathlon TS inserts are available in sequentially crosslinked and standard polyethylene.

#### Intended Use:

The Triathlon TS Total Knee System tibial components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All tibial components presented in this submission are provided sterile for single-use.

# Indications for Use

General Total Knee Arthroplasty (TKR) 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 knee replacement or other procedure.
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture . management techniques

Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. .

Additional Indications for Total Stabilizer (TS) Components:

- Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.

#### Substantial Equivalence:

The determination of substantial equivalence of the Triathlon TS Total Knee System tibial inserts is based on its similarities in indications for use, intended use, design and sterilization to Howmedica Osteonics' Triathlon TS Total Knee System (K070095, cleared June 01, 2007).

{2}------------------------------------------------

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2007

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

Re: K072221

Trade/Device Name: Triathlon® TS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 27, 2007 Received: September 28, 2007

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, 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

{3}------------------------------------------------

# Page 2 - Ms. Tiffani Rogers

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.

Darbage Buelin
Sen

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): _ K072221

Device Name:

## Indications for Use

General Total Knee Arthroplasty (TKR) 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 knee replacement or other procedure. .
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture ● management techniques

# Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:

- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. .

#### Additional Indications for Total Stabilizer (TS) Components:

- Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.

Prescription Use

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 of General, Restorative, and Neurological 510(k) I