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FDA 510(k)

GLOBAL ICON Stemless Shoulder System

K-Number: K212683 · 2022-01-19

ApplicantDepuy(Ireland)
Decision Date2022-01-19
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL ICON Stemless Shoulder System is a medical device manufactured by Depuy(Ireland). It received FDA 510(k) clearance on 2022-01-19 under approval number K212683. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL ICON Stemless Shoulder System?

GLOBAL ICON Stemless Shoulder System is a medical device that received FDA 510(k) clearance on 2022-01-19. It is manufactured by Depuy(Ireland). The 510(k) number is K212683.

When was GLOBAL ICON Stemless Shoulder System approved by the FDA?

GLOBAL ICON Stemless Shoulder System received FDA 510(k) clearance on 2022-01-19, under approval number K212683.

What company makes GLOBAL ICON Stemless Shoulder System?

GLOBAL ICON Stemless Shoulder System is manufactured by Depuy(Ireland).

What is the FDA product code for GLOBAL ICON Stemless Shoulder System?

The FDA product code for GLOBAL ICON Stemless Shoulder System is PKC.

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) PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

Other Devices by Depuy(Ireland)

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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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