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FDA 510(k)

Incompass Total Ankle System

K-Number: K250037 · 2025-06-20

ApplicantWright Medical Technology, Inc. (Stryker)
Decision Date2025-06-20
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Incompass Total Ankle System is a medical device manufactured by Wright Medical Technology, Inc. (Stryker). It received FDA 510(k) clearance on 2025-06-20 under approval number K250037. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Incompass Total Ankle System?

Incompass Total Ankle System is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Wright Medical Technology, Inc. (Stryker). The 510(k) number is K250037.

When was Incompass Total Ankle System approved by the FDA?

Incompass Total Ankle System received FDA 510(k) clearance on 2025-06-20, under approval number K250037.

What company makes Incompass Total Ankle System?

Incompass Total Ankle System is manufactured by Wright Medical Technology, Inc. (Stryker).

What is the FDA product code for Incompass Total Ankle System?

The FDA product code for Incompass Total Ankle System is HSN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Wright Medical Technology, Inc. (Stryker)

K241999Prophecy Surgical Planning System

Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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