510(k) K252898
K252898 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper". The FDA issued a decision of Substantially Equivalent on December 15, 2025. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2025
- Date Received
- September 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3510
- Review Panel
- OR
- Submission Type