The Triathlon® Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® Total Knee System is intended for cementless use only.

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. .

The Triathlon® Total Knee System beaded and beaded with Peri-apatite components are intended for uncemented use only.

Device Description

The Triathlon® Total Knee System will be available with femoral and tibial components in a cementless design with and without Stryker Howmedica Osteonics' Peri-apatite (PA) coating. The Triathlon® fixed bearing cementless baseplate and femoral components are compatible with the current Triathlon® tibial inserts and patellas. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a PA coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8. The femoral components will be offered in both cruciate retaining (CR) and posterior stabilizing (PS) versions, also in sizes 1 through 8.

AI/ML Overview

This is a medical device 510(k) summary for the Triathlon® Total Knee System. It details the device's identity, indications for use, and a declaration of substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

This document does not present acceptance criteria or a study proving the device meets them in the way a diagnostic AI would. Instead, it is a Premarket Notification (510(k)) summary, which is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device.

For a medical device like a total knee replacement system, "acceptance criteria" are typically met through adherence to established consensus standards (e.g., ISO standards for biomechanical testing, material biocompatibility), design and manufacturing controls, and clinical performance data that has been gathered on the predicate devices over time.

Instead of a table of acceptance criteria and reported device performance in the context of an AI study, the relevant information for this 510(k) is:

Criterion Type	Description
Intended Use	The Triathlon® Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
Indications for Use	Painful, disabling joint disease of the knee from noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus, or flexion deformity where ligamentous structures can be returned to function/stability; revision of previous unsuccessful knee replacement; fracture of distal femur/proximal tibia not stabilizable by standard techniques. Additional indications for PS components: ligamentous instability requiring increased constraint, absent/non-functioning PCL.
Substantial Equivalence	Based on similarities in intended use, design, and sterilization to predicate devices: Howmedica Osteonics' Triathlon® PS Total Knee System (K042993), Triathlon® CR Total Knee System (K040267), Duracon® Total Knee System (K032163, K032418). (Predicate device information is in Appendix D, not provided here).
Device Design/Materials	Femoral and tibial components available in cementless design, with/without Peri-apatite (PA) coating. Fixed bearing cementless baseplate and femoral components compatible with current Triathlon® tibial inserts and patellas. Manufactured from cast cobalt chrome with a cobalt chrome porous coating, with/without PA coating. Tibial component is fixed bearing, sizes 1-8. Femoral components in CR and PS versions, sizes 1-8.

Information Not Applicable or Not Provided in this Document for AI/Diagnostic Studies:

The following points are typically relevant for AI/diagnostic device studies, but are not applicable or not provided in this 510(k) summary for a knee implant:

Sample size used for the test set and the data provenance: This document does not describe a "test set" in the context of an AI or diagnostic study. The "testing" for this orthopedic implant would involve biomechanical bench testing, materials characterization, and potentially clinical experience with the predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant is clinical outcome, successful integration, and long-term function, established through clinical follow-up, not expert image review.
Adjudication method for the test set: Not applicable.
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, as this is not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For an implant, ground truth would be real-world clinical outcomes (e.g., pain relief, restoration of function, implant survival, absence of complications) over time. This 510(k) relies on the established safety and effectiveness of the predicate devices.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document is a regulatory submission demonstrating substantial equivalence for an orthopedic implant, not a study reporting on the performance of a diagnostic or AI device. The "proof" of meeting acceptance criteria lies in its substantial equivalence to already legally marketed devices, which have a history of safe and effective use.

Summary

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AUG 3 0 2005

OSTEONICS

325 Corporate Drive 510(k) Summary of Safety and Effectiveness for the Mahwah, NJ USA 07430 Triathlon® Total Knee System

Proprietary Name:	Triathlon™ Total Knee System
Common Name:	Total Knee Joint Replacement Prosthesis
Classification Name and Reference	Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis.21 CFR §888.3565
Regulatory Class:	Class II
Device Product Code:	87 MBH - prosthesis, knee,patello/femorotibial, semi-constrained,uncemented, porous, coated,polymer/metal/polymer,
For Information contact:	Tiffani RogersRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07432Phone: (201) 831-5412Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:	August 11, 2005

Device Description

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The femoral components will be offered in both cruciate retaining (CR) and posterior stabilizing (PS) versions, also in sizes 1 through 8.

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. .

Substantial Equivalence:

The determination of the substantial equivalence of the Triathlon® Total Knee System is based on its similarities in intended use, design and sterilization to Howmedica Osteonics' Triathlon® PS Total Knee System (K042993, cleared January 12, 2005), Triathlon® CR Total Knee System (K040267, cleared May 05, 2004), Duracon® Total Knee System (K032163, cleared September 12, 2003 and K032418 cleared, September 11, 2003). Predicate device information is located in Appendix D.

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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are arranged on a single line, with "Public Health" appearing before "Service". The text is simple and straightforward, likely serving as a heading or label.

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

AUG 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tiffani Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051380 K051580
Trade/Device Name: Triathlon® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: August 11, 2005 Received: August 13, 2005

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We nave reviewed your Security promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manatinent date of the Medical Device American be and Food. Fore commerce prior to May 28, 1776, the encenters with the provisions of the Federal Food. Drug. devices that have been reclassified in accerdance "rius can as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) that do not require approvision the general controls provisions of the Act. The You may, therefore, market the devrees, books of the Act annual registration, listing of general controls provisions of the Feet 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 If your device is classified (300 abor b) als. Existing major regulations affecting your device can may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peaces and one one one on the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- s issuation of a backers.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal Statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), adoning (21 CFR Part 820); good if applicable, the electronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Tiffani Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manxellig your device of your device to a legally premarket notification. THC PDA miang of 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 If you desire specific advice for your at 110 %. Also, please note the regulation entitled, the regulation entitled, colliact the Office of Computers as (21 trotification" (21CFR Part 807.97). You may obtain " Misoranding by relevelec to premance to premance the Act from the Division of Small
on of Small other general information on your responsibilities and its toll-free number (800) 638-204 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerety yours,

Sincerely yours,

Mark N. Melkerson

Acting 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): ____K051380

Device Name: Triathlon® Total Knee System ____________________________________________________________________________________________________________________________________

Indications

Painful, disabling joint disease of the knee resulting from: noninflammatory . r unrai, assasting joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
Post-traumatic loss of knee joint configuration and function. .
r ost traintanes, 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:

I identions instability requiring implant bearing surface geometries with . increased constraint.
Absent or non-functioning posterior cruciate ligament. .

The Triathlon® Total Knee System beaded and beaded with Peri-apatite components are intended for uncemented use only.

Prescription Use Use___________________________________________________________________________________________________________________________________________________________________________

Over-the-Counter

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Devies Evaluation (ODE)

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

510(k) Number Ko51380

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.