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FDA 510(k)

Resolve Modular Revision Hip Stem

K-Number: K242315 · 2025-05-01

ApplicantUnited Orthopedic Corporation
Decision Date2025-05-01
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Resolve Modular Revision Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K242315. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resolve Modular Revision Hip Stem?

Resolve Modular Revision Hip Stem is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is United Orthopedic Corporation. The 510(k) number is K242315.

When did Resolve Modular Revision Hip Stem receive FDA 510(k) clearance?

Resolve Modular Revision Hip Stem received FDA 510(k) clearance on 2025-05-01, under 510(k) number K242315.

Who is the listed applicant for Resolve Modular Revision Hip Stem?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resolve Modular Revision Hip Stem?

The FDA product code for Resolve Modular Revision Hip Stem is MEH.

Other records listing United Orthopedic Corporation 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.

K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaK243466Conformity Stem Extension Line, #0K243024Cellbrick Knee SpacerK242249Conformity Stem Extension Line

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K243839Alteon® HA Femoral StemsExactech, Inc.K243162World LinerSignature Orthopaedics Pty, Ltd.

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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