K253159
- 510(k) number
- K253159
- Device name
- Prophecy Incompass Surgical Planning System
- Applicant
- Wright Medical Technology, Inc. (Stryker) TN · US
- Product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal
- Decision date
- 2026-06-16
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K253159.pdf
Official FDA record: K253159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.