K250037
- 510(k) number
- K250037
- Device name
- Incompass Total Ankle System
- Applicant
- Wright Medical Technology, Inc. (Stryker) TN · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2025-06-20
- Date received
- 2025-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250037.pdf
Official FDA record: K250037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.