K253161
- 510(k) number
- K253161
- Device name
- Balanced Knee System TriMax Porous Femoral Components
- Applicant
- Ortho Development Corp. UT · US
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2025-12-19
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253161.pdf
Official FDA record: K253161
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.