Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

FDA cleared the Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper from Howmedica Osteonics Corp., Dba Stryker Orthopaedics on Dec 15, 2025 under K252898, a traditional 510(k). The device falls under product code KRO, Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, regulated at 21 CFR 888.3510 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 11, 2025. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Howmedica Osteonics Corp., Dba Stryker Orthopaedics has 4 other decisions in the tracker over the last 12 months: K261898 (Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System), K261624 (Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component), K253637 (Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert), K252044 (Triathlon® Total Knee System - Triathlon® Gold Femoral Components).