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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 the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology, Inc. (Stryker). It received FDA 510(k) clearance on 2025-06-20 under 510(k) 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. The listed applicant is Wright Medical Technology, Inc. (Stryker). The 510(k) number is K250037.

When did Incompass Total Ankle System receive FDA 510(k) clearance?

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

Who is the listed applicant for Incompass Total Ankle System?

The FDA 510(k) record lists Wright Medical Technology, Inc. (Stryker) as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Wright Medical Technology, Inc. (Stryker) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemK251643Synchfix EVTK252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)K241999Prophecy Surgical Planning System

Related Devices (Code: HSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K242868Kinos Total Ankle SystemRestor3D

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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