Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Device Description

The Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.

AI/ML Overview

This document, K071881, pertains to the 510(k) summary for the Triathlon® PKR System, a knee prosthesis. It focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information based on your request:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The submission's primary "acceptance criteria" for the 510(k) clearance process is demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and operational principles.
Reported Device Performance: The document states that "Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market." However, no specific performance metrics (e.g., wear rate, fatigue strength values, range of motion, clinical outcomes) or a comparison table against acceptance criteria are provided in this summary. Instead, it refers to "mechanical testing" generally.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence through design and material comparisons and the mention of general mechanical testing, not a clinical study with a test set of patients.

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)

This information is not applicable/not provided. Ground truth establishment by experts for a test set is typically relevant for studies evaluating diagnostic or AI-driven devices. This submission concerns a physical implant (knee prosthesis).

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

This information is not applicable/not provided for the same reasons as point 3.

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

This information is not applicable/not provided. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of images with or without AI assistance. This submission does not describe such a study.

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

This information is not applicable/not provided. This device is a physical knee implant, not an algorithm.

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

For the purpose of substantial equivalence for a physical implant, the "ground truth" is typically established through:
- Material properties and design specifications: Demonstrating that the materials and design conform to established standards and are equivalent to predicate devices.
- Mechanical testing: In vitro laboratory tests (e.g., fatigue, wear, strength) serve as the "ground truth" for demonstrating the physical robustness and performance characteristics under simulated conditions. The summary mentions "mechanical testing" but does not detail the specific tests or their results.
- Clinical history of predicate devices: The long-standing safe and effective use of the predicate devices implicitly forms a "ground truth" for the intended use and performance expectations.

8. The sample size for the training set

This information is not applicable/not provided. A "training set" is relevant for machine learning algorithms, not for the regulatory submission of a physical medical device like a knee prosthesis.

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

This information is not applicable/not provided for the same reason as point 8.

Summary

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510(k) Summary of Safety and Effectiveness Triathlon® Knee System Line Extension

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430

Vivian Kelly, Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5581 Fax: (201) 831-6038

Date Summary Prepared:

Device Identification

Proprietary Name: Common Name: Classification Name and Reference:

Proposed Regulatory Class: Device Panel/Product Code: July 6, 2007

Triathlon® PKR System Knee Prosthesis Components Knee Joint, Femorotibial, Polymer/Metal, Semi-constrained, Cemented Prosthesis, 21 CFR §888.3530 Class II 87 HRY, Prosthesis, Knee, Femorotibial, semi-constrained, Cemented, Metal/Polymer

Description:

Indications for Use:

Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Substantial Equivalence:

The device is substantially equivalent to its predicates for femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analyses demonstrate that the components from these systems are compatible when used for femorotibial replacement. Examples of predicate knee systems include the Triathlon® Knee System (K031729, K040267) and X30 UHMWPE Tibial Inserts and Patellar Components (K051146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K911373) and the UNIX™ Unicompartmental Knee System (K923011.) Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2007

Howmedica Osteonics Corp. % Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

Re: K071881

Trade/Device Name: Triathlon PKR System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: July 6, 2007 Received: July 9, 2007

Dear Ms. Kelly:

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. Iisting 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 mav 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

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Page 2 - Ms. Vivian Kelly

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Ambare Bnehn

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): K071881

Device Name: Triathlon® PKR System

Indications for Use:

Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
Revision of previous unsuccessful surgical procedures, either involving, or not ◆ involving, previous use of a unicompartmental knee prosthesis
. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.

These components are intended for implantation with bone cement.

Prescription Use Over-The-Counter Use 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)

Chau Buehly Nixon
Division Sign. Off

Page 1 of 1

Division of General, Restorative
and Neurological Devices

510(k) Number K071881

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.