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FDA 510(k)

SMR Reverse HP Shoulder System

K-Number: K243826 · 2025-07-03

ApplicantLima Corporate S.P.A.
Decision Date2025-07-03
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Reverse HP Shoulder System is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2025-07-03 under approval number K243826. 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 Reverse HP Shoulder System?

SMR Reverse HP Shoulder System is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K243826.

When was SMR Reverse HP Shoulder System approved by the FDA?

SMR Reverse HP Shoulder System received FDA 510(k) clearance on 2025-07-03, under approval number K243826.

What company makes SMR Reverse HP Shoulder System?

SMR Reverse HP Shoulder System is manufactured by Lima Corporate S.P.A..

What is the FDA product code for SMR Reverse HP Shoulder System?

The FDA product code for SMR Reverse HP Shoulder System is PHX.

Related Clinical Trials

NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05357378 Safety and Effectiveness of the HIT Reverse HRS RECRUITING NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07464977 EMG and Delta Function in Standard RTSA vs Lateralization NOT_YET_RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED

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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