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FDA 510(k)

INHANCETM Shoulder System – Humeral Stems and Stemless

K-Number: K223211 · 2022-12-02

ApplicantDepuy Ireland UC
Decision Date2022-12-02
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INHANCETM Shoulder System – Humeral Stems and Stemless is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2022-12-02 under approval number K223211. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INHANCETM Shoulder System – Humeral Stems and Stemless?

INHANCETM Shoulder System – Humeral Stems and Stemless is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Depuy Ireland UC. The 510(k) number is K223211.

When was INHANCETM Shoulder System – Humeral Stems and Stemless approved by the FDA?

INHANCETM Shoulder System – Humeral Stems and Stemless received FDA 510(k) clearance on 2022-12-02, under approval number K223211.

What company makes INHANCETM Shoulder System – Humeral Stems and Stemless?

INHANCETM Shoulder System – Humeral Stems and Stemless is manufactured by Depuy Ireland UC.

What is the FDA product code for INHANCETM Shoulder System – Humeral Stems and Stemless?

The FDA product code for INHANCETM Shoulder System – Humeral Stems and Stemless is PHX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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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