K252454
- 510(k) number
- K252454
- Device name
- Kinos Total Ankle System
- Applicant
- Restor3D NC · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2025-09-03
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252454.pdf
Official FDA record: K252454
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.