K253637
- 510(k) number
- K253637
- Device name
- Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2026-02-18
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253637.pdf
Official FDA record: K253637
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.