FDA 510(k)

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

K-Number: K252404 · 2026-04-15

Decision Date2026-04-15

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is a medical device manufactured by Biomet Orthopedics. It received FDA 510(k) clearance on 2026-04-15 under approval number K252404. 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 Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by Biomet Orthopedics. The 510(k) number is K252404.

When was Comprehensive Reverse Shoulder - HA Glenosphere Baseplates approved by the FDA?

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates received FDA 510(k) clearance on 2026-04-15, under approval number K252404.

What company makes Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is manufactured by Biomet Orthopedics.

What is the FDA product code for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

The FDA product code for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is PHX.

Related Clinical Trials

NCT06921265 Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia ENROLLING_BY_INVITATION NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07464977 EMG and Delta Function in Standard RTSA vs Lateralization NOT_YET_RECRUITING NCT06788717 MDR - Comprehensive Primary Revision Stems PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Biomet Orthopedics

K200196Taperloc® Complete Hip Stems K223631Comprehensive Segmental Revision System(SRS) K243761A.L.P.S. Small Fragment Plating System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.