The intended use of the size one Triathlon™ Cruciate Retaining Tibial Insert is the same as that of the predicate device described in premarket notification K040267 – it is intended for use with Triathlon™ Cruciate Retaining femoral components, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. The cruciate retaining design is intended to accommodate the posterior cruciate ligament if it is present.

Indications:

· Painful, disabling joint disease of the knee resulting from: nonimflammatory 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.

Device Description

This premarket notification describes a smaller size of Triathlon™ Cruciate Retaining Tibial Insert. This smaller size insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ CR Femoral component in primary or revision total knee arthroplasty. This size I tibial insert has smaller anterior-posterior and medio-lateral dimensions than the size 2 predicate.

AI/ML Overview

This document is a Special 510(k) Premarket Notification for a new size of a previously cleared device. It primarily focuses on demonstrating substantial equivalence to the predicate device and does not contain information about acceptance criteria, efficacy studies, or performance benchmarks as would be found in a clinical trial report.

Therefore, the requested information cannot be extracted from the provided text. The document is a regulatory submission for a Class II medical device, which often relies on demonstrating equivalence rather than comprehensive clinical performance studies to the extent that a new drug or high-risk device might.

Specifically, the document does NOT contain the following information:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
Results of a standalone algorithm performance study.
Type of ground truth used for performance evaluation.
Sample size for the training set.
How the ground truth for the training set was established.

The document states: "This premarket notification describes a smaller size of Triathlon™ Cruciate Retaining Tibial Insert. This smaller size insert is intended to be used with the size 1 Triathlon™ Primary Cemented Tibial Tray and the Triathlon™ CR Femoral component in primary or revision total knee arthroplasty." It then lists the intended use, which is identical to the predicate device. This confirms that the submission is for a minor modification (new size) to an existing, cleared device, and thus leverages the predicate's established safety and effectiveness. Studies demonstrating performance against acceptance criteria are typically not required for such modifications; rather, the focus is on showing that the new size does not introduce new safety or efficacy concerns compared to the predicate.

Summary

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NOV 2 3 2004

Size 1 Triathlon™ CR Tibial Insert

Special 510(k) Premarket Notification

K042883

Special 510(k) Summary

Proprietary Name:

Size 1 Triathlon™ Cruciate Retaining (CR) Tibial Insert

Common Name:

Modular Tibial Insert

Classification Name and Reference:

Proposed Regulatory Class: Device Product Code:

Predicate Proprietary Name: Predicate Regulatory Class: Predicate Product Code:

For Information contact:

Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR $888.3560

Class II 87 JWH

Triathlon™ CR Tibial Insert - Sizes 2-8 Class II 87 JWH

Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430 Phone: (201) 831-5612 Fax: (201) 831-6038

Description/Technological Comparison

Page 3

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Size 1 Triathlon™ CR Tibial Insert

Special 510(k) Premarket Notification

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dimensions than the size 2 predicate.

Intended Use

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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 features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2004

Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K042883

Trade/Device Name: Size 1 Triathlon™ Cruciate Retaining (CR) 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: October 15, 2004 Received: October 19, 2004

Dear Ms. Duchene:

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 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 - Ms. Denise Duchene

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device: Size 1 Triathlon™ CR Tibial Insert____________________________________________________________________________________________________________________________________

The Triathlon™ CR Size 1 tibial inserts are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below:

Indications:

· Painful, disabling joint disease of the knee resulting from: nonimflammatory 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.
· 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	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number	K042883
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Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.