Triathlon® Total Knee System - Triathlon® Gold Femoral Components

{0} FDA U.S. FOOD & DRUG ADMINISTRATION October 24, 2025 Howmedica Osteonics Corp. dba Stryker Orthopaedics Shing Jen Tai Principal Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430 Re: K252044 Trade/Device Name: Triathlon® Total Knee System - Triathlon® Gold Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: June 30, 2025 Received: September 25, 2025 Dear Shing Jen Tai: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252044 - Shing Jen Tai Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K252044 - Shing Jen Tai Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely,  Lixin Liu, Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} Triathlon® Total Knee System - Triathlon® Gold Femoral Components Page 20 of 53 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252044 | ? | | Please provide the device trade name(s). | | ? | | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | | | | Please provide your Indications for Use below. | | ? | | 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 | | | | The Triathlon® Gold Femoral Components are indicated for both uncemented and cemented use. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ? | | | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | {4} K252044 Page 1 of 4 # 510(k) Summary Sponsor Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 Contact Person Shing Jen Tai Principal Regulatory Affairs Specialist Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 269-800-2088 Shingjen.tai@stryker.com Alternate Contact Margaret Klippel Chief Regulatory Affairs Specialist Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 201-831-5559 Margaret.klippel@stryker.com Date Prepared: June 30, 2025 Proprietary Name: Triathlon® Total Knee System – Triathlon® Gold Femoral Components Common Name: Total Knee Joint Replacement Prosthesis Classification Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR 888.3565) Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560) Product Codes: MBH; JWH {5} K252044 Page 2 of 4 # Legally Marketed Primary and Additional Predicate Devices to Which Substantial Equivalence is Claimed: - Triathlon™ Total Knee System - K051380 (Primary Predicate) - Omni TiN Coated Apex Knee™ System - K191765 (Additional predicate) # Legally Marketed Reference Devices Used to Support Substantial Equivalence: - Triathlon® Tritanium® Tibial Baseplates – K123486 - Exactech Truliant® Porous Tibial Tray and Alteon Bone Screws – K182346 - Biocore9 Acetabular Cup System - K212761 - Endotec B-P Hemispherical Acetabular Component - K963101 - Trident® II Tritanium® Acetabular Shells and 6.5mm Low Profile Hex Screw - K161569 - Smith & Nephew Legion Primary Knee System - K093746 # Reason for 510(k) Submission: The purpose of this Traditional 510(k) Premarket Notification is to introduce the new Triathlon® Gold Femoral Components as a line extension of the previously cleared Triathlon® cruciate retaining (CR) femoral components within the Triathlon® Total Knee System. This submission proposes adding the Triathlon® Gold Femoral Components to the system as an additional CR femoral component option that is 1) manufactured from titanium alloy (Ti-6Al-4V) and fully coated with Titanium Nitride (TiN), and 2) for uncemented and cemented use. Addition of these femoral components does not change the intended use, indications for use, operational principles, or fundamental scientific technology of the Triathlon® Total Knee System. # Device Description: The Triathlon® Total Knee System is a total knee prosthesis designed to resurface the articulating surface of the femoral and tibial bones. In a total knee replacement, Triathlon® Gold Femoral Components are intended to replace the articulating surface of the distal femur and articulate against an articular surface of the tibial component as well as an optional patellar component. Triathlon® Gold Femoral Components are additively manufactured from Ti-6Al-4V powder, using Electron Beam Melting (EBM) technology, and then fully coated with titanium nitride (TiN), using Physical Vapor Deposition (PVD). In addition to TiN coating, the bone cut facing surfaces of these femoral components contain the Tritanium® porous structure. Indicated for both uncemented and cemented use, the subject femoral components are provided in right and left configurations and eight proportional sizes (sizes 1-8) for a total of 16 unique components to accommodate differences in patient anatomy. The subject femoral components are sterile, single use devices. {6} K252044 Page 3 of 4 ## Intended Use: The subject device is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. ## 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 The Triathlon® Gold Femoral Components are indicated for both uncemented and cemented use. ## Summary of Technological Characteristics: The device comparisons and performance testing show that the subject Triathlon® Total Knee System – Triathlon® Gold Femoral Components are substantially equivalent to the predicate devices based on intended use, indications for use, design, materials, technical and performance characteristics, and operational principles that do not raise different questions of safety and effectiveness. ## Non-Clinical Testing: The following non-clinical laboratory testing and engineering analyses were performed to determine substantial equivalence: - Physical characterization of the porous surfaces - Chemical characterization of the porous surfaces - Mechanical characterization of the porous surfaces - Chemical characterization of the solid surface - Mechanical characterization of the solid surface - Characterization of TiN coating - Femoral fatigue testing - Coating adhesion verification testing - Tibial-femoral and patella-femoral engineering analyses - Femoral backside engineering analysis - Clean wear testing - Third body wear testing {7} K252044 Page 4 of 4 - MRI Safety testing - Biocompatibility evaluation ## Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence. ## Conclusion: The subject Triathlon® Total Knee System – Triathlon® Gold Femoral Components are substantially equivalent to the primary predicate Triathlon™ Total Knee System (K051380) and additional predicate Omni TiN Coated Apex Knee™ System (K191765) based on intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data that do not raise different questions of safety and effectiveness.