K253793
- 510(k) number
- K253793
- Device name
- Materialise TKA Guide System
- Applicant
- Materialise NV BE
- Product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
- Decision date
- 2026-01-06
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253793.pdf
Official FDA record: K253793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.