The Triathlon™ PS Total Knee system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of the articular surface of the patella is required, the Duracon® patellar components are compatible with the Triathlon™components). The Triathlon™ PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. Specific indications and contraindications for the Triathlon™ PS Total Knee System are listed below:

Indications:

Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative ioint 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 Triathlon™ Posteriorly Stabilized Total Knee System consists of three primary components: Triathlon™ Posteriorly Stabilized (PS) Femoral Component, Triathlon™ Primary Cemented Tibial Baseplate, and Triathlon™ Posteriorly Stabilized (PS) Tibial Insert. Optional Triathlon™ Femoral Distal Fixation Pegs are also available. If replacement of the articular surface of the patella is required, the Duracon® patellar components are intended for use with the Triathlon™ Posteriorly Stabilized Femoral Components.

The Triathlon™ Total Knee Posteriorly Stabilized Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.

The Triathlon™ Total Knee Posteriorly Stabilized Femoral Component is available in right and left configurations, and eight proportional sizes to accommodate differences in patient anatomy. The interior surface of the component (except the interior surface of the PS box) is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features an intercondylar box that engages the mating tibial insert eminence at 45° to 60° (depending upon size of implant). The superior portion of the box is open box design is intended to reduce contact on the tibial insert eminence, and in the case of intra-operative or postoperative femoral fracture, allow the surgeon to use a retrograde femoral nail to treat the fracture. There are threaded attachment features on the distal and posterior aspects of the femoral component. The threaded attachment feature on the distal aspect of the component is to allow the use of modular pegs.

The Triathlon™ Primary Cemented Tibial Tray is fabricated from cast cobalt chromium molybdenum alloy. The Triathlon" Primary Cemented Tibial Tray is neutral in configuration, and is available in eight proportional sizes. The undersurface of the tibial trav and the keel is grit blasted for interdigitation with PMMA bone cement. The keel of the tibial tray is designed with normalizations for rotational stability and cement interdigitation. The superior aspect of the tibial tray has a rim that contains tabs that mate with the outer periphery of the tibial insert, along with the locking wire used on the tibial insert. This locking feature is designed to provide secure attachment of the tibial insert to the tray, and is designed to reduce micromotion of the tibial insert on the tray.

The Triathlon™ Posteriorly Stabilized (PS) Tibial Insert is neutral in configuration, and is available in eight proportional sizes and varying thicknesses (9mm, 11mm, 13mm, 16mm, 19mm, 22mm, and 25mm). The insert is fabricated from ultra high molecular weight polyethylene and cobalt-chromium alloy. The minimum thickness of the tibial insert on the bearing surface is 6mm. The tibial insert features a tibial eminence (or post) that provides anterior/posterior constraint in clinical situations where the posterior cruciate ligament is absent or non-functional. As previously noted, the tibial eminence contacts the cam of the femoral component at 45-60 degrees of flexion. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.

The Triathlon "PS Tibial Insert incorporates a locking wire feature on the anterior aspect of the insert. This locking wire is fabricated from cobalt-chromium alloy, and engages under tabs on the anterior rim of the Triathlon™ Primary Tibial Baseplate. This wire-tab locking mechanism secures the insert into the baseplate.

Triathlon™ Distal Femoral Fixation Pegs are made available separate from the Triathlon™ Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon™ PS Femoral Component, and are optional for use. These pegs are designed to provide rotational stability, and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon™ Distal Femoral Fixation Pegs are fabricated from wrought cobalt chromium alloy. The distal portion of the fixation peg is threaded to allow the peg to be assembled to the distal threaded hole in the Triathlon™ PS Femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral component.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Triathlon™ Posteriorly Stabilized (PS) Total Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study design, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The document states:
"Testing was presented to support a claim of substantial equivalence to the predicate devices." (Page 4, {4} of 5)
And in the FDA's response letter:
"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..." (Page 5, {5} of 5)

This indicates that any testing performed aimed to show that the Triathlon™ system performs as safely and effectively as existing, legally marketed knee replacement systems, rather than against specific, predefined numerical acceptance criteria. The nature of these "tests" would typically involve bench testing (e.g., mechanical strength, wear resistance) rather than clinical studies with human participants that generate data for metrics like sensitivity, specificity, or reader improvement.

To directly answer your request based only on the provided text, the following points cannot be extracted:

A table of acceptance criteria and the reported device performance: Not present. This document focuses on substantial equivalence, not performance against specific criteria.
Sample sized used for the test set and the data provenance: Not present. No clinical test set details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth establishment for a clinical test set is not applicable here.
Adjudication method for the test set: Not present. Adjudication for a clinical test set is not applicable here.
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 present. This device is a physical knee implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present. Not applicable to a physical medical device.
The type of ground truth used: Not present. Not applicable in this context.
The sample size for the training set: Not present. No training set is mentioned as this is not an AI/algorithm-based device.
How the ground truth for the training set was established: Not present. Not applicable.

Summary

{0}------------------------------------------------

K031729 Page 1 of 5

Triathlon™ Posteriorly Stabilized (PS) Total Knee System

510(k) Premarket Notification	Confidential
SEP - 2 2003	510(k) Summary
Submission Information
Name and Address of Sponsor:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401
For Information contact:	Margaret F. CroweRegulatory Affairs ConsultantHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401
Device Identification
Proprietary Name:	Triathlon™ Posteriorly Stabilized (PS) Total Knee System
Common Name:	Posteriorly Stabilized Total Knee Replacement
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

{1}------------------------------------------------

Indications:

Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative ioint 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.

{2}------------------------------------------------

Device Description

{3}------------------------------------------------

K031729 PAGE 4 of 5

{4}------------------------------------------------

Triathlon™ Posteriorly Stabilized (PS) Total Knee System Confidential 510(k) Premarket Notification

of the femoral component on the prepared distal femur. The Triathlon™ Distal Femoral Fixation Pegs are fabricated from wrought cobalt chromium alloy. The distal portion of the fixation peg is threaded to allow the peg to be assembled to the distal threaded hole in the Triathlon™ PS Femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral component.

Equivalent products include:

1. Duracon® Monolithic Stabilizer Femoral Component
1. Duracon® Cruciform Tibial Baseplate
1. Duracon® PS Lipped Tibial Insert
1. Scorpio® Posteriorly Stabilized (PS) Total Knee System
1. Series 7000 Standard Tibial Tray

Testing was presented to support a claim of substantial equivalence to the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a black and white logo. The logo features a stylized bird with three parallel lines forming its body and wings. The bird is facing left. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2003

Mr. William J. Cymbaluk Vice President Ouality Assurance/Regulatory Affairs/Clinical Research Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K031729

Trade/Device Name: Triathlon™ Posteriorly Stabilized (PS) Total Knee System Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: June 3, 2003 Received: June 4, 2003

Dear Mr. Cymbaluk:

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.

{6}------------------------------------------------

Page 2 - Mr. William J. Cymbaluk

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 (301) 594-4659. 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.

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

{7}------------------------------------------------

Triathlon™ Posteriorly Stabilized (PS) Total Knee System 510(k) Premarket Notification

510(k) Number (if known): K 03 1729

Triathlon™ Posteriorly Stabilized (PS) Total Knee System Device:

The Triathlon PS Total Knee system is comprised of femoral components, tibial trays, and tibial inserts that are intended to be used with the patellar components of the Duracon® system in primary and revision total knee arthroplasty. The Triathlon™ PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. Specific indications and contraindications for the Triathlon PS Total Knee System are listed below:

Indications:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative ioint 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

{8}------------------------------------------------

K031729 PAGE 2 of 2

· 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.

The Triathlon™ PS Femoral Component and the Triathlon™ Primary Cemented Tibial Baseplate are intended to be implanted using bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use 801.109)

Over-the Counter-Use

for Mark N Millaser
(Division Sign-Off)

eral. Restorative Neurological Devices

510(k) Number K031729

20f2

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.