Prophecy Incompass Surgical Planning System— 510(k) K253159
Substantially EquivalentWright Medical Technology, Inc. (Stryker)
FDA 510(k) clearance K253159 for Prophecy Incompass Surgical Planning System, Substantially Equivalent on 2026-06-16. Applicant: Wright Medical Technology, Inc. (Stryker). Device class: 2.
Summary
The Prophecy Incompass Surgical Planning System, from Wright Medical Technology (Stryker), is filed under HSN, semi-constrained, cemented metal/polymer ankle prostheses. The name describes a planning system while the code name is an ankle prosthesis, and the record doesn't explain the fit.
Class II, 21 CFR 888.3110. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Wright Medical filed from Memphis, Tennessee. Review took 263 calendar days (September 26, 2025 to June 16, 2026).
Clearance details
- Applicant
- Wright Medical Technology, Inc. (Stryker)
- Product code
- Product code HSN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3110
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code HSN
view allMore clearances from Wright Medical Technology, Inc. (Stryker)
view allAdverse events under product code HSN
product code HSN- Death
- 3
- Injury
- 4,711
- Total
- 4,714
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.