Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GLOBAL UNITE™ Platform Shoulder System

K-Number: K202098 · 2020-11-25

ApplicantDepuy Ireland UC
Decision Date2020-11-25
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL UNITE™ Platform Shoulder System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2020-11-25 under approval number K202098. 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 GLOBAL UNITE™ Platform Shoulder System?

GLOBAL UNITE™ Platform Shoulder System is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Depuy Ireland UC. The 510(k) number is K202098.

When was GLOBAL UNITE™ Platform Shoulder System approved by the FDA?

GLOBAL UNITE™ Platform Shoulder System received FDA 510(k) clearance on 2020-11-25, under approval number K202098.

What company makes GLOBAL UNITE™ Platform Shoulder System?

GLOBAL UNITE™ Platform Shoulder System is manufactured by Depuy Ireland UC.

What is the FDA product code for GLOBAL UNITE™ Platform Shoulder System?

The FDA product code for GLOBAL UNITE™ Platform Shoulder System is PHX.

Related Clinical Trials

NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT06578104 PULSED AF Post-Approval Study RECRUITING NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT03636230 Virtual E-health System for Pacemakers ACTIVE_NOT_RECRUITING

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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) 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 UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System K193057ATTUNE All-Polyethylene Tibia

View all 48 devices →

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.

↑