The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Indications For Use:

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

Device Description

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the Triathlon® CS (Condylar Stabilizing) Lipped Insert. This document is related to a knee implant component, not an AI/ML-driven diagnostic or prognostic device. Therefore, much of the information requested in your prompt regarding AI/ML study design (such as sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable.

The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a knee implant component), the "acceptance criteria" are demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and operational principles, rather than performance metrics typically seen in AI/ML studies (like sensitivity, specificity, or AUC). The reported "performance" relates to its physical characteristics and how they compare to established implants.

Acceptance Criterion (Demonstrates Substantial Equivalence to Predicates)	Reported Device Performance (Comparison)
Intended Use (Primary and revision total knee arthroplasty to alleviate pain and restore function)	States intended use is "substantially equivalent to other modular tibial inserts"
Design (Lipped insert compatible with specific femoral and baseplate components, similar anterior constraint to Triathlon® CR insert allowing PCL retention/sacrifice)	Compared to Duracon® CS Lipped Tibial Insert, Triathlon® CR Tibial insert, and Triathlon® PS insert. "Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market."
Materials (Polymer)	States materials are "substantially equivalent to other modular tibial inserts"
Operational Principles (Mechanism of action within the knee joint)	States operational principles are "substantially equivalent to other modular tibial inserts"
Biomechanical Performance (Range of Constraint, Contact Area/Peak Stress)	"The results demonstrate that the subject components are substantially equivalent to the predicate components." (Specific values are not provided in this summary)

2. Sample Size for Test Set and Data Provenance

Not applicable for this type of submission. This is a medical device (implant) and its equivalence isn't typically demonstrated through a "test set" of patient data in the way an AI/ML algorithm would be. The "test" for this device involves engineering analysis, material testing, and potentially bench testing, not clinical data sets for performance evaluation against a ground truth.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no "ground truth" establishment in the context of clinical images or data for this engineering-focused substantial equivalence. The "experts" involved would be engineers, materials scientists, and regulatory specialists evaluating the design and testing of the implant.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device that assists human readers.

6. Standalone Performance Study

While the device undergoes extensive standalone engineering and material testing (e.g., fatigue testing, wear testing, range of motion, contact stress analysis), these are not presented as "standalone performance" in the context of an algorithm's output. The summary explicitly states: "Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market." This indicates engineering performance testing was conducted, but specific details or test results are not provided in this regulatory summary.

7. Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety of the predicate devices and fundamental engineering and biomechanical principles for knee implants. Compliance with these established standards and the demonstrated equivalence to existing safe and effective devices serve as the basis for regulatory acceptance.

8. Sample Size for the Training Set

Not applicable.

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

Not applicable.

Summary Conclusion for this Specific Device:

This 510(k) summary demonstrates the substantial equivalence of the Triathlon® CS (Condylar Stabilizing) Lipped Insert to predicate devices, thereby establishing its safety and effectiveness without needing extensive new clinical trials or AI-specific performance metrics. The "study" here refers to the comparative analysis of its design, materials, and biomechanical properties against legally marketed knee implant components, conforming to engineering standards and principles rather than statistical performance on patient data.

Summary

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510(k) Summary of Safety and Effectiveness

Triathlon® CS (Condylar Stabilizing) Lipped Insert		JAN 2 2 2007
Proprietary Name:	Triathlon® CS (Condylar Stabilizing) Lipped Insert
Common Name:	Modular Tibial Insert
Classification Name/Reference:	Knee Joint PatellofemorotibialPolymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis21 CFR §888.3560Knee Joint; Patellofemorotibial; Metal/polymer;Porous-coated; Uncemented prosthesis21 CFR 888.3565
Device Product Code:	87 JWH87 MBH
Proposed Regulatory Class:	Class II
For Information contact:	Sheryl R. Bagalio, RAC Regulatory AffairsSpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5314 Fax: (201) 831-6038
Date Summary Prepared:	January 10, 2007

Description:

Intended Use:

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The

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Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.

Indications For Use:

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

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. Page 1 of 2
Bone stock compromised by disease, infection or prior implantation which 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 which can lead to failure of the fixation of the device or to failure of the device itself.

Substantial Equivalence:

The Triathlon® CS (Condylar Stabilizing) Lipped Insert is substantially equivalent to other modular tibial inserts regarding intended use, design, materials, and operational principles such as the Duracon® CS Lipped Tibial Insert cleared under K021451, K023724 and K032163, the Triathlon® CR Tibial insert cleared under K040267, K042883 and K051146, and the Triathlon® PS insert cleared under K031729, K050539 and K051146. Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market. The results demonstrate that the subject components are substantially equivalent to the predicate components.

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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 consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2007

Howmedica Osteonics Corporation % Sheryl R. Bagalio, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K063423

Trade/Device Name: Triathlon® CS (Condylar Stabilizing) Lipped Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH Dated: January 10, 2007 Received: January 12, 2007

Dear Ms. Bagalio:

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

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Page 2 - Sheryl R. Bagalio, RAC

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 vours.

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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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Indications for Use

510(k) Number (if known): K063423

Device Name: Triathlon® CS (Condylar Stabilizing) Lipped Insert

Intended Use:

Indications For Use:

. 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

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. Page 1 of 2

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Bone stock compromised by disease, infection or prior implantation which 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 . which can lead to failure of the fixation of the device or to failure of the device itself.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sion-Division of General, Restorative, and Neurological Devices

510(k) Number 1063423

Page 2 of 2

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.