TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT

K063423 · Howmedica Osteonics · JWH · Jan 22, 2007 · Orthopedic

Device Facts

• Record ID: K063423
• Device Name: TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
• Applicant: Howmedica Osteonics
• Product Code: JWH · Orthopedic
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Device Story

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is a modular tibial component for total knee arthroplasty. It functions as a mechanical interface within the knee joint, providing anterior constraint similar to the Triathlon® CR insert, allowing surgeons to retain or sacrifice the Posterior Cruciate Ligament (PCL). It is compatible with various Triathlon® femoral components and baseplates. Used in clinical settings by orthopedic surgeons during primary or revision knee replacement procedures to restore joint function and alleviate pain. The device is provided sterile for single use.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence was established through mechanical testing comparing range of constraint and contact area/peak stress against predicate devices.

Technological Characteristics

Modular tibial insert for total knee arthroplasty. Semiconstrained design. Materials and construction are consistent with predicate modular tibial inserts. Device is provided sterile for single use.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (noninflammatory degenerative joint disease, osteoarthritis, traumatic arthritis, avascular necrosis, or rheumatoid arthritis); post-traumatic loss of knee configuration/function; moderate varus, valgus, or flexion deformity with stable ligamentous structures; revision of unsuccessful knee replacement; or distal femur/proximal tibia fractures. Contraindicated in patients with active/latent knee infection, distant infection foci, mental/neuromuscular disorders risking instability/fixation failure, compromised bone stock, skeletal immaturity, severe instability due to collateral ligament absence, 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

• Duracon® CS Lipped Tibial Insert (K021451, K023724, K032163)
• Triathlon® CR Tibial insert (K040267, K042883, K051146)
• Triathlon® PS insert (K031729, K050539, K051146)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

| Triathlon® CS (Condylar Stabilizing) Lipped Insert | | JAN 2 2 2007 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Proprietary Name: | Triathlon® CS (Condylar Stabilizing) Lipped Insert | |
| Common Name: | Modular Tibial Insert | |
| Classification Name/Reference: | Knee Joint Patellofemorotibial<br>Polymer/Metal/Polymer Semi-Constrained<br>Cemented Prosthesis<br>21 CFR §888.3560<br><br>Knee Joint; Patellofemorotibial; Metal/polymer;<br>Porous-coated; Uncemented prosthesis<br>21 CFR 888.3565 | |
| Device Product Code: | 87 JWH<br>87 MBH | |
| Proposed Regulatory Class: | Class II | |
| For Information contact: | Sheryl R. Bagalio, RAC Regulatory Affairs<br>Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] | |
| Date Summary Prepared: | January 10, 2007 | |

## Description:

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).

Intended Use:

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The

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Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Indications For Use:

- 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

## 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. Page 1 of 2
- Bone stock compromised by disease, infection or prior implantation which 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 which can lead to failure of the fixation of the device or to failure of the device itself.

## Substantial Equivalence:

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is substantially equivalent to other modular tibial inserts regarding intended use, design, materials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlon® PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market. The results demonstrate that the subject components are substantially equivalent to the predicate components.

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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 & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2007

Howmedica Osteonics Corporation % Sheryl R. Bagalio, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K063423

> Trade/Device Name: Triathlon® CS (Condylar Stabilizing) Lipped Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH Dated: January 10, 2007 Received: January 12, 2007

Dear Ms. Bagalio:

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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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#### Page 2 - Sheryl R. Bagalio, RAC

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 vours.


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): K063423

Device Name: Triathlon® CS (Condylar Stabilizing) Lipped Insert

Intended Use:

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Indications For Use:

- . 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

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. Page 1 of 2

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- Bone stock compromised by disease, infection or prior implantation which 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 . which can lead to failure of the fixation of the device or to failure of the device itself.

Prescription Use Over-The-Counter Use X 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)

Sion-Division of General, Restorative, and Neurological Devices

**510(k) Number** 1063423

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