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.

Device Description

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device modification, specifically the Triathlon™ Posterior Stabilized (PS) Tibial Insert. It does not contain information about a study proving the device meets acceptance criteria, nor does it discuss acceptance criteria in terms of performance metrics that would typically be evaluated in a study (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific physical performance characteristics for a therapeutic device).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the primary requirement for a 510(k) submission. Therefore, most of the requested information, which pertains to a clinical or performance study, cannot be extracted from the provided text.

Here is an analysis based on the information available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or reported device performance in the manner requested (e.g., accuracy percentages, physical test results with pass/fail thresholds). The "acceptance criteria" for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device. The primary performance metric mentioned is "improved rotational constraint" for the modified tibial insert. However, no quantitative data or specific acceptance criteria for this improvement are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes a medical device modification submitted for 510(k) clearance, not a study evaluating performance with a test set of data (clinical or otherwise).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment is described as there is no performance study presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described as there is no performance study presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a joint replacement component; MRMC studies are not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a joint replacement component; standalone algorithm performance is not relevant to this type of device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth is mentioned as there is no performance study presented. The comparison is made to a predicate device based on design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this document does not describe the development or evaluation of an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable.

Summary of Available Information:

The provided document describes a modification to an existing medical device: the size 1 Triathlon™ Posterior Stabilized (PS) Tibial Insert. The purpose of the 510(k) submission is to demonstrate that this modified device is substantially equivalent to a legally marketed predicate device (K031729).

Acceptance Criteria (Implied by 510(k) process): The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This involves showing similar intended use, indications for use, technological characteristics, and safety and effectiveness.
Device Performance (as stated in document): The modification "has been modified for improved rotational constraint with the size 1 insert." No quantitative data or specific test results proving this improved constraint are provided in this regulatory summary.
Study: The document does not describe a clinical study or a performance study with acceptance criteria of the kind typically requested for AI/ML or diagnostic devices. Instead, it is a regulatory submission comparing a modified device to a predicate. The "study" implicitly refers to the comparison of the modified device's characteristics (design, materials, intended use) against the predicate.
Ground Truth / Training Set / Test Set / Experts: These concepts are not applicable to the content of this 510(k) summary, as it is not a performance study of a diagnostic algorithm or a clinical trial.

Summary

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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: (201) 831-5718 Fax: (201) 831-6038 March 21, 2005 Date Prepared:

Description/Technological Comparison

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
Page 2 of 2

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 (301) 443-6597 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:

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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K050539 Page 22 of of 2 =

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 _____________________________________________________________________________________________________________________________________________________________

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

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.