Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

FDA cleared the Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System from Howmedica Osteonics Corp. dba Stryker Orthopaedics on Aug 6, 2026 under K261898, 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 Jun 5, 2026. The decision came 62 days later, inside the 90 FDA-day goal for a 510(k).

Howmedica Osteonics Corp. dba Stryker Orthopaedics has 4 other decisions in the tracker over the last 12 months: 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), K252898 (Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper), K252044 (Triathlon® Total Knee System - Triathlon® Gold Femoral Components).