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FDA 510(k)

Trivicta® Hip Stem

K-Number: K251052 · 2025-05-22

ApplicantOrtho Development Corp.
Decision Date2025-05-22
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Trivicta® Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K251052. 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 Trivicta® Hip Stem?

Trivicta® Hip Stem is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Ortho Development Corp.. The 510(k) number is K251052.

When did Trivicta® Hip Stem receive FDA 510(k) clearance?

Trivicta® Hip Stem received FDA 510(k) clearance on 2025-05-22, under 510(k) number K251052.

Who is the listed applicant for Trivicta® Hip Stem?

The FDA 510(k) record lists Ortho Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trivicta® Hip Stem?

The FDA product code for Trivicta® Hip Stem is MEH.

Other records listing Ortho Development Corp. 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.

K253161Balanced Knee System TriMax Porous Femoral ComponentsK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK233093Balanced Knee® System TriMax PS Plus Tibial InsertK211086The Progen™ Trochanteric Nail System

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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.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® 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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