# K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper - Pathway: 510(k) (Traditional) - Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics - Decided: Dec 15, 2025 after 95 days - Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer) - Device class: 2 - Regulation: 21 CFR 888.3510 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 14 generations back to K943462 (1994). 114 ancestors in all. No later device cites it as a predicate yet. 0 of 115 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K242831: Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2024) Summary page 7. - K132624: Triathlon Tritanium Metal-Backed Patella, Stryker Orthopaedics (2013) Summary page 7. - K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 7. - K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 7. - K972967: Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total Knee Recessed Patellar Component, Osteonics Corp. (1998) Summary page 7. - K243817: Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025) Summary page 7. - K223528: Triathlon® Hinge Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 7. - K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®, Stryker (2023) Summary page 7. - K251665: Triathlon® Hinge Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025) Summary page 7. ## Recalls of this device - Jul 30, 2026 · Class II · Z-3206-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m ## Indications for use Triathlon® Symmetric and Asymmetric Patella • 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. Triathlon® Tritanium® Asymmetric and Symmetric Patella • 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 Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use. Triathlon® Hinge Bumper Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s): • There is destruction of the joint surfaces, with or without significant bone deformity. • The cruciate and/or collateral ligaments do not stabilize the knee joint. • The ligaments are inadequate and/or the musculature is weak. And/or • Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis: • Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with compatible GMRS components: • Where segmental resection and/or replacement of femur and/or proximal tibia is required. Scorpio® Universal Dome Patella • 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. Source page: https://510kreport.com/device/K252898 Methodology: https://510kreport.com/methodology