SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT

K050539 · Howmedica Osteonics Corp. · JWH · Mar 29, 2005 · Orthopedic

Device Facts

• Record ID: K050539
• Device Name: SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 – it is intended for use with Triathlon™ PS femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The Posterior stabilized design is primary of revision collection cruciate ligament if it is absent or non-functioning.

Device Story

Triathlon™ Posterior Stabilized (PS) Tibial Insert is a modular orthopedic implant component for total knee arthroplasty. Device serves as articulating surface within knee joint replacement system; functions with Triathlon™ PS femoral components and primary cemented tibial trays. Modification to size 1 insert provides improved rotational constraint. Implanted by orthopedic surgeons in clinical/hospital settings during primary or revision cemented total knee arthroplasty. Device replaces damaged or diseased joint surfaces; restores joint configuration and stability; compensates for absent or non-functioning posterior cruciate ligament. Patient benefits include pain relief and improved joint function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular tibial insert for knee arthroplasty. Material: Polymer (implied UHMWPE per standard knee prosthesis classification). Design: Posterior stabilized, semi-constrained. Form factor: Size 1 insert. Energy source: None (mechanical implant). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis); post-traumatic loss of knee function; moderate varus, valgus, or flexion deformity; revision of failed knee replacement; or distal femur/proximal tibia fractures. Additional indications include ligamentous instability or absent/non-functioning posterior cruciate ligament. Contraindicated in patients with active/latent infection, distant foci of infection, mental/neuromuscular disorders, compromised bone stock, skeletal immaturity, severe collateral ligament instability, or obesity.

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™ Posterior Stabilized Tibial Insert (K031729)

Submission Summary (Full Text)

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MAR 2 9 2005

Kosos39

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### Special 510(k) Summary

Size 1 Triathlon™ Posterior Stabilized (PS) Proprietary Name: Tibial Insert Modular Tibial Insert Common Name: Knee Joint Patellofemorotibial Classification Name and Reference: Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR §888.3560 Class II Proposed Regulatory Class: 87 JWH Device Product Code: Triathlon™ PS Tibial Insert - Sizes 1 Predicate Proprietary Name: Class II Predicate Regulatory Class: 87 JWH Predicate Product Code: Karen Ariemma For Information contact: Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430 Phone: [phone] Fax: [phone] March 21, 2005 Date Prepared:

### Description/Technological Comparison

This premarket notification describes a modification to the articulating surface of the size 1 Triathlon™ Posterior Stabilized Tibial Insert. This insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ PS Femoral component in primary or revision total knee arthroplasty. This size 1 tibial insert has been modified for improved rotational constraint with the size 1 insert.

### Intended Use

The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 - it is intended for use with Triathlon™ Posterior Stabilized femoral components, Triathlon™

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K050539
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Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The Posterior stabilized design is primary of revision collection cruciate ligament if it is absent or non-functioning.

## Indications:

- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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 Components:

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

# Contraindications

- · Any active or suspected latent infection in or about the knee joint.
- · Distant foci of infection which may cause hematogenous spread to the implant site
- · Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- · Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
- · Skeletal immaturity.
- · Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- · Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of an abstract human figure with three wavy lines emanating from it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

MAR 2 9 7005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Susan Krasny, Ph.D., RAC Director, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K050539

Device Name: Triathlon™ Knee System Posterior Stabilized (PS) Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 28, 2005

Dear Dr. Krasny:

Received: March 2, 2005

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 mcan 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 - Dr. Susan Krasny, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I his letter will anow you to vegal missantial equivalence of your device to a legally marketed predicate notification: "The I Dry Intellig of scounting 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 (240) 276-_. Also, please note the regulation entitled, "Misbranding by the Office of Comphaneo at (210) 210 - 10 - 1 Part 807.97). You may obtain other general information on four responsibilities under the Act from the Division of Small Manufacturers, International and Consumer your responsibilities and its toll 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K050539 510(k) Number (if known):

# Device Name: Triathlon™ Knee System - Posterior Stabilized (PS) Tibial Inserts

### Intended Use:

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The intended use of the size one Triathlon™ Posterior Stabilized Tibial Insert is the same as that of the predicate device described in premarket notification K031729 – it is intended for use with Triathlon™ PS femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications/contraindications are listed below (these are identical to the predicate):

### Indications:

- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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 Components:

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

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#### Contraindications

- · Any active or suspected latent infection in or about the knee joint.
- · Distant foci of infection which may cause hematogenous spread to the implant site
- · Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- · Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
- · Skeletal immaturity.
- · Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- · Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.

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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number k050539