The intended use of the Triathlon™ PS Femoral Component is: it is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications:

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

The modified Triathlon™ PS Femoral Component (catalog number 5515) is identical to the previously released Triathlon™ PS Femoral Component in terms of intended use, material, and general design features. The only difference is the removal of material from the superior, posterior portion of the cam. Physical testing was performed to show that the component could withstand load over ten million cycles.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and the supporting study:

The provided document describes a 510(k) premarket notification for a design modification of a knee femoral component. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving a novel device's performance against clinical acceptance criteria.

Key takeaway: This 510(k) submission is for a material removal design change to an existing device (Triathlon™ PS Femoral Component, previously cleared under K031729). The acceptance criteria and "study" described are focused on demonstrating that this minor design change does not negatively impact the device's original performance and that it remains substantially equivalent to the predicate. Therefore, the information provided is not a typical clinical study proving the device meets performance acceptance criteria against a ground truth in the way one might expect for a new diagnostic or prognostic device.

Here's the breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from 510(k))	Reported Device Performance
Mechanical Durability: The modified component must withstand physiological loading without failure.	The component "could withstand load over ten million cycles" in physical testing.
Material Equivalence: The material of the modified component must be the same as the predicate.	The modified component is "identical to the previously released Triathlon™ PS Femoral Component in terms of intended use, material, and general design features" (with the exception of the removed material).
Functional Equivalence: The design modification should not alter the articular surface designs or intended function.	"The articular surface designs of the component (both patello-femoral and tibio-femoral) are unchanged by this modification."
Manufacturability: The design change should improve manufacturability.	"This material is being removed to improve manufacturability of the component." This is the primary driver for the change.
Intended Use & Indications: The modified device must retain the same intended use and indications as the predicate.	"The intended use of the Triathlon™ PS Femoral Component is identical to that of the predicate." (Specific indications are listed).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the traditional sense for a clinical test set. The "test set" here refers to the physical component that underwent testing. The document refers to "the component" as a singular item rather than a specified quantity.
Data Provenance: The testing was "Physical testing" performed on the modified component. There's no information about country of origin or whether it's retrospective/prospective clinical data; it's laboratory/bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving human interpretation or ground truth established by experts in the context of clinical data. The "ground truth" for mechanical durability is derived from mechanical testing standards and engineering principles.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 is not a study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the assessment of this mechanical device is based on mechanical engineering principles and established testing standards for orthopedic implants, specifically regarding fatigue life and structural integrity under simulated physiological loads. The acceptance criterion is typically defined by these standards (e.g., ISO standards for knee implants, or internal company standards validated against such). The document states the component "could withstand load over ten million cycles," which is a common benchmark for fatigue testing in orthopedic implants.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Kb 42993

Triathlon™ Posteriorly Stabilized (PS Femoral Component (5515) Confidential 510(k) Premarket Notification

JAN 1 2 2005

510(k) Summary

Mahwah, NJ 07430

Submission Information

Howmedica Osteonics Corp. Name and Address of Sponsor: 325 Commerce Court Mahwah, NJ 07430 Denise Duchene For Information contact: Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Commerce Court
Device Identification

Proprietary Name:	Triathlon™ Posteriorly Stabilized (PS) FemoralComponent (5515)
Common Name:	Posteriorly Stabilized Knee Femoral Component
Classification Name and Reference:	Knee Joint PatellofemorotibialPolymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis21 CFR §888.3560
Proposed Regulatory Class:	Class II
Device Product Code:	OR(87) JWHProsthesis, Knee Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/ Polymer

It is the intention of Howmedica Osteonics Corp. to modify the design of the Triathlon™ Posteriorly Stabilized (PS) Femoral Component (previously released under K031729) to improve component manufacturability.

The design change for the Triathlon™ PS Femoral Component involves a removal of material from the superior, posterior region of the cam (or box) section of the femoral

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component adjacent to the posterior femoral condyles. This material is being removed to improve manufacturability of the component. The articular surface designs of the component (both patello-femoral and tibio-femoral) are unchanged by this modification.

The intended use of the Triathlon™ PS Femoral Component is identical to that of the predicate: it is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications and contraindications are listed below:

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.

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· 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.

Device Description

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corp 325 Commerce Court Mahwah, New Jersey 07430

Re: K042993

Trade/Device Name: Triathlon™ Posteriorly Stabilized PS Femoral Component (5515) Regulation Name: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/ metal/ polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 29, 2004 Received: November 1, 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) 276-0210. 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/industry/support/index.html.

Sincerely yours,

Mark A. Wilkerson

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) Premarket Notification- Triathlon™ PS Femoral Component (5515)

510(k) Number (if known): K

Triathlon™ Posteriorly Stabilized (PS) Femoral Component (5515) Device:

The Triathlon™ PS Femoral Component has undergone a design modification - material has been removed from the superior, posterior aspect of the cam. This design change has been made to improve the manufacturability of the component. The intended use of the Triathlon™ PS Femoral Component is: it is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. Specific indications:

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 criciate li

I. Restorative. Division of Gener and Neurological Devices

Page 1 of 2

142

510(k) Number.

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Prescription Usc X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerm

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

Koy 2993 510(k) Number

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.