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FDA 510(k)

Arthrex Radial Head Replacement System

K-Number: K260624 · 2026-07-30

ApplicantArthrex, Inc.
Decision Date2026-07-30
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Radial Head Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K260624. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Radial Head Replacement System?

Arthrex Radial Head Replacement System is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Arthrex, Inc.. The 510(k) number is K260624.

When did Arthrex Radial Head Replacement System receive FDA 510(k) clearance?

Arthrex Radial Head Replacement System received FDA 510(k) clearance on 2026-07-30, under 510(k) number K260624.

Who is the listed applicant for Arthrex Radial Head Replacement System?

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

What is the FDA product code for Arthrex Radial Head Replacement System?

The FDA product code for Arthrex Radial Head Replacement System is KWI.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: KWI)

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.

K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLCK183618Revolution Radial HeadIgnite Orthopedics, Inc.

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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