The Triathlon TS Total Knee System tibial components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All tibial components presented in this submission are provided sterile for single-use.

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic 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 (PS) and Total Stabilizer (TS) Components:

Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.
Severe anteroposterior instability of the knee joint.

Additional Indications for Total Stabilizer (TS) Components:

Severe instability of the knee secondary to compromised collateral ligament integrity or function.
The Triathlon TS Total Knee System components are intended for cemented use only.

Device Description

The Triathlon TS Total Knee System features TS and TS Plus tibial inserts available in sizes 1 through 8 and thicknesses from 9mm to 31mm. These tibial inserts used with the Triathlon TS Total Knee System have been modified. The tibial inserts feature an open cam box with a tibial post slot to accommodate a cobalt chrome tibial post intended for additional stability in the knee joint. The Triathlon TS tibial inserts also feature a metal locking wire for assembly into previously cleared Triathlon tibial baseplates. The Triathlon TS Plus and the Triathlon TS inserts are available in sequentially crosslinked and standard polyethylene.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Triathlon® TS Knee System," a total knee joint replacement prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through a study with acceptance criteria in the typical sense of a medical device with an algorithm or AI.

Therefore, many of the questions regarding acceptance criteria, study performance, sample sizes, expert ground truth, and AI involvement are not applicable to this 510(k) submission.

Here's a breakdown of the relevant information provided, and where the requested details are not applicable:

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

Not Applicable. For a 510(k) submission of a knee implant, acceptance criteria are generally demonstrated through similarities in design, materials, and intended use to a predicate device, along with verification and validation of manufacturing processes (which are not detailed in this public summary). Performance is largely inferred from the predicate device's established safety and effectiveness. There isn't a direct "acceptance criteria" table with reported performance metrics in the way one would see for a diagnostic device or AI algorithm.

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. This submission is for a knee implant, demonstrating substantial equivalence through design and material comparisons to a predicate device. It does not involve a "test set" of patient data in the context of an algorithm's performance.

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. See point 2.

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

Not Applicable. See point 2.

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 device is a physical knee implant and does not involve AI or human "readers."

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

Not Applicable. This device is a physical knee implant and does not involve an algorithm.

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

Not Applicable. In the context of a 510(k) for a physical implant, "ground truth" relates to the established safety and performance of the predicate device, engineering analyses, and material testing, rather than a diagnostic 'ground truth' based on clinical data.

8. The sample size for the training set

Not Applicable. This submission does not involve a "training set" in the context of an algorithm or AI.

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

Not Applicable. See point 8.

Summary of the 510(k) Submission (What is provided):

The document describes the Triathlon® TS Knee System, specifically focusing on modifications to the TS and TS Plus tibial inserts. The submission seeks to demonstrate substantial equivalence to a previously cleared device, the Howmedica Osteonics' Triathlon TS Total Knee System (K070095, cleared June 01, 2007).

Device Description: The Triathlon TS Total Knee System features TS and TS Plus tibial inserts in various sizes and thicknesses. The modifications include an open cam box with a tibial post slot for a cobalt chrome tibial post (for additional stability), and a metal locking wire for assembly. Inserts are available in sequentially crosslinked and standard polyethylene.
Intended Use: Primary and revision total knee arthroplasty to alleviate pain and restore function.
Indications for Use:
- General TKR: Painful, disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis), post-traumatic loss of knee joint configuration, moderate deformities where ligaments can be returned to function, revision of previous unsuccessful knee replacements, and unreconstructable fractures of the distal femur/proximal tibia.
- Additional for PS and TS Components: Ligamentous instability requiring increased constraint, absent or non-functioning posterior cruciate ligament, severe anteroposterior instability.
- Additional for TS Components: Severe instability due to compromised collateral ligament integrity or function.
- All components are for cemented use only.
Substantial Equivalence: The determination of substantial equivalence is based on similarities in indications for use, intended use, design, and sterilization to the predicate device (K070095).

In essence, this 510(k) asserts that the modified Triathlon TS Knee System tibial inserts are as safe and effective as their predicate device because their fundamental characteristics (purpose, how they're used, their physical form, and how they're prepared for use) are sufficiently similar, despite minor design changes. The "study" in this context is the comparison against the predicate device and the engineering rationale for the design changes.

Summary

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007 1 5 2007

Howmedica
OSTEONICS

325 Corporate Drive Mahwah, NJ USA 07430

510(k) Summary of Safety and Effectiveness for the Triathlon® TS Knee System

Proprietary Name:	Triathlon® TS Knee System
Common Name:	Total Knee Joint Replacement Prosthesis
Classification Name and Reference	Joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis.21 CFR §888.3560
Regulatory Class:	Class II
Device Product Code:	87 JWH - prosthesis, knee, patellofemorotibial,semi-constrained, cemented,polymer/metal/polymer
For Information contact:	Tiffani RogersRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07432Phone: (201) 831-5612Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:	August 8, 2007

Device Description

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previously cleared Triathlon tibial baseplates. The Triathlon TS Plus and the Triathlon TS inserts are available in sequentially crosslinked and standard polyethylene.

Intended Use:

Indications for Use

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic 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 (PS) and Total Stabilizer (TS) Components:

Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
Absent or non-functioning posterior cruciate ligament. .
Severe anteroposterior instability of the knee joint. .

Additional Indications for Total Stabilizer (TS) Components:

Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.

Substantial Equivalence:

The determination of substantial equivalence of the Triathlon TS Total Knee System tibial inserts is based on its similarities in indications for use, intended use, design and sterilization to Howmedica Osteonics' Triathlon TS Total Knee System (K070095, cleared June 01, 2007).

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2007

Howmedica Osteonics Corp. % Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432

Re: K072221

Trade/Device Name: Triathlon® TS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 27, 2007 Received: September 28, 2007

Dear Ms. Rogers:

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

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Page 2 - Ms. Tiffani Rogers

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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Darbage Buelin
Sen

Mark N. Me kerson 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): _ K072221

Device Name:

Indications for Use

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, ● rheumatoid arthritis or post-traumatic 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 (PS) and Total Stabilizer (TS) Components:

Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
Absent or non-functioning posterior cruciate ligament. .
Severe anteroposterior instability of the knee joint. .

Additional Indications for Total Stabilizer (TS) Components:

Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.

Prescription Use

OR 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) Division of General, Restorative, and Neurological 510(k) I

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.