# K250037: Incompass Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical Technology, Inc. (Stryker)
- Decided: Jun 20, 2025 after 163 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: 10 generations back to K920802 (1992). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193067: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System, Wrightmedicaltechnologyinc (2020) Summary page 5.
- (no number) Inbone Total Ankle System: named in the summary without a submission number
- (no number) Infinity Total Ankle System: named in the summary without a submission number

## Most influential descendants
- K253159: Prophecy Incompass Surgical Planning System (2026), 0 descendants of its own

## Indications for use
Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

Source page: https://510kreport.com/device/K250037
Methodology: https://510kreport.com/methodology