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FDA 510(k)

APEX 3D Total Ankle Replacement System

K-Number: K250641 · 2025-05-01

ApplicantParagon 28, Inc.
Decision Date2025-05-01
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX 3D Total Ankle Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K250641. 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 APEX 3D Total Ankle Replacement System?

APEX 3D Total Ankle Replacement System is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Paragon 28, Inc.. The 510(k) number is K250641.

When did APEX 3D Total Ankle Replacement System receive FDA 510(k) clearance?

APEX 3D Total Ankle Replacement System received FDA 510(k) clearance on 2025-05-01, under 510(k) number K250641.

Who is the listed applicant for APEX 3D Total Ankle Replacement System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APEX 3D Total Ankle Replacement System?

The FDA product code for APEX 3D Total Ankle Replacement System is HSN.

Other records listing Paragon 28, Inc. as applicant

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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 SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)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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