# K253159: Prophecy Incompass Surgical Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical Technology, Inc. (Stryker)
- Decided: Jun 16, 2026 after 263 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K920802 (1992). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131283: Prophecy Infinity Preoperative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2013) Summary page 5.
- K241999: Prophecy Surgical Planning System, Wright Medical Technology, Inc. (Stryker) (2024) Summary page 5.
- K202815: PROPHECY Preoperative Navigation Alignment System, Wrightmedicaltechnologyinc (2021) Summary page 5.
- K250037: Incompass Total Ankle System, Wright Medical Technology, Inc. (Stryker) (2025) Summary page 5.

## Indications for use
Prophecy® Surgical Planning is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®, Infinity®, Invision®, and Incompass™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning Guides are intended for single use only.

Source page: https://510kreport.com/device/K253159
Methodology: https://510kreport.com/methodology