510(k) K250037

Incompass Total Ankle System by Wright Medical Technology, Inc. (Stryker) — Product Code HSN

K250037 is an FDA 510(k) premarket notification submitted by Wright Medical Technology, Inc. (Stryker) for the device "Incompass Total Ankle System". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Wright Medical Technology, Inc. (Stryker) has at least 2 other 510(k) clearances on record.