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FDA 510(k)

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

K-Number: K252352 · 2026-01-22

ApplicantLima Corporate S.P.A.
Decision Date2026-01-22
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2026-01-22 under approval number K252352. 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 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K252352.

When was SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System approved by the FDA?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System received FDA 510(k) clearance on 2026-01-22, under approval number K252352.

What company makes SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is manufactured by Lima Corporate S.P.A..

What is the FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

The FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is PHX.

Related Clinical Trials

NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy 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)

Other Devices by Lima Corporate S.P.A.

K160011H-Max S stem K161476SMR Shoulder System K153722SMR 3-Pegs Glenoids K170473C2 femoral stem K163397SMR Hybrid Glenoid System K161120SMR TT Metal Back Glenoid, Bone Graft instruments

View all 41 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.

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