K251665
- 510(k) number
- K251665
- Device name
- Triathlon® Hinge Knee System
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
- Product code
- KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemente
- Decision date
- 2025-07-25
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251665.pdf
Official FDA record: K251665
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.