Cleared Traditional

Incompass Total Ankle System

K250037 · Wright Medical Technology, Inc. (Stryker) · Orthopedic

Jun 2025

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K250037 is an FDA 510(k) clearance for the Incompass Total Ankle System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Wright Medical Technology, Inc. (Stryker) (Memphis, US). The FDA issued a Cleared decision on June 20, 2025, 163 days after receiving the submission on January 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K250037 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2025
Decision Date	June 20, 2025
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110