K251771
- 510(k) number
- K251771
- Device name
- Cambridge Partial Knee
- Applicant
- Signature Orthopaedics Pty, Ltd. AU
- Product code
- HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cem
- Decision date
- 2025-12-16
- Date received
- 2025-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251771.pdf
Official FDA record: K251771
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.