K261563
- 510(k) number
- K261563
- Device name
- Freedom Total Knee System (E-Poly Tibial Liners)
- Applicant
- Maxx Orthopedics, Inc. PA · US
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2026-08-07
- Date received
- 2026-05-11
- 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: K261563.pdf
Official FDA record: K261563
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.