The Triathlon TS Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All total knee 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: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), 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.
Indications for Bone Augments:
. Painful, disabling joint disease of the knee secondary to: degenerative arthritis. rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.
Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.

The Triathlon TS Total Knee System components are intended for cemented use only.

Device Description

A total stabilizing version of the Triathlon Total Knee System has been developed and will now include femoral components and tibial inserts compatible with the Triathlon universal tibial components cleared previously. The new Triathlon TS Knee is designed to accommodate patients with severely deficient bone stock who require additional components for increased stabilization. The Triathlon TS System will include femoral components, stem extenders, offset adapters, stems, and tibial inserts in standard and TS Plus design. Implants will be available in sizes 1 through 8. Product descriptions, product codes and engineering drawings are provided for review.

AI/ML Overview

This document describes the Triathlon® TS Knee System, a total knee joint replacement prosthesis. However, the provided text does not contain information regarding objective acceptance criteria or a study that specifically proves the device meets such criteria.

The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a de novo clinical study with predefined acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this submission.

Here's a breakdown based on the available information and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable / Not Provided. The 510(k) summary does not include an objective performance study with specific acceptance criteria that the Triathlon® TS Knee System was evaluated against. Instead, it relies on demonstrating substantial equivalence to predicate devices based on similarities in design, materials, and intended use.

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

Not Applicable / Not Provided. No "test set" in the context of a performance study is mentioned. The submission relies on establishing substantial equivalence to existing, legally marketed devices.

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

Not Applicable / Not Provided. Since no formal performance study with a test set requiring ground truth establishment is described, this information is not present.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided. No adjudication method is mentioned as there is no described test set requiring one.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on design and indications for use, not comparative effectiveness with human readers or AI assistance.

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

Not Applicable / No. This device is a physical knee prosthesis, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is irrelevant.

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

Not Applicable / Not Provided. As no formal study with a "ground truth" is described, this information is absent. The basis for safety and effectiveness is substantial equivalence to predicates.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided. This device is a physical implant, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable / Not Provided. (Refer to point 8).

Summary of what the K070095 document does provide:

Device Description: A total stabilizing version of the Triathlon Total Knee System, including femoral components, tibial inserts, stem extenders, offset adapters, and stems.
Intended Use and Indications for Use: Clearly states the purpose of the device for primary and revision total knee arthroplasty, and specific conditions for its use, including ligamentous instability and severe bone loss.
Substantial Equivalence: The primary method of demonstrating safety and effectiveness is through comparison to existing predicate devices:
- Howmedica Total Stabilizing Total Knee System (K973164)
- Triathlon PS Knee System (K031729 and K042993)
- Triathlon® Total Knee System (K053514)
Regulatory Clearance: The FDA letter confirms the review and determination of substantial equivalence, allowing the device to be marketed.

In essence, this 510(k) submission relies on the regulatory pathway of substantial equivalence, where a new device is deemed as safe and effective as an already legally marketed predicate device, rather than requiring a new, de novo clinical trial with explicit acceptance criteria and performance study data.

Summary

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K070095 510(k) Summary of Safety and Effectiveness for the Triathlon® TS Knee System

JUN - 1 2007

Proprietary Name:	Triathlon® TS Knee System
Common Name:	Total Knee Joint Replacement Prosthesis
Classification Name and Reference	Joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented 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) 831-5412Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:	June 1, 2007

Device Description

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Intended Use:

Indications for Use

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), 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.

Indications for Bone Augments:

. Painful, disabling joint disease of the knee secondary to: degenerative arthritis. rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.
Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.

The Triathlon TS Total Knee System components are intended for cemented use only.

Substantial Equivalence:

The determination of the substantial equivalence of the Triathlon TS total knee system is based on similarities in intended use, design and sterilization to the Howmedica Total Stabilizing Total Knee System (K973164, cleared August 22, 1997), Triathlon PS Knee System (K031729, cleared September 2, 2003 and K042993 cleared January 12, 2005) and the Triathlon® Total Knee System (K053514, cleared January 26, 2006).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2007

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

Re: K070095

Trade/Device Name: Triathlon TS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 17, 2007 Received: May 18, 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 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. Tiffani D. Rogers

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Alvin M. McRaven
City Sign Off

090095

Division of General. Restorative, and Neurological Devices

510(k) Number

510(k) Number (if known):

Device Name: Triathlon® TS Knee System

Indications for Use

General Total Knee Arthroplasty (TKR) Indications:

Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), 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.

Indications for Bone Augments:

Painful, disabling joint disease of the knee secondary to: degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.
. Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

The Triathlon TS Total Knee System components are intended for cemented use only.

x Over-the-Counter Use Prescription Use OR (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)

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.