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FDA 510(k)

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

K-Number: K251184 · 2025-05-16

ApplicantEncore Medical L.P.
Decision Date2025-05-16
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2025-05-16 under approval number K251184. 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 AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System?

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Encore Medical L.P.. The 510(k) number is K251184.

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

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System received FDA 510(k) clearance on 2025-05-16, under approval number K251184.

What company makes AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System?

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System is manufactured by Encore Medical L.P..

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

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

Related Clinical Trials

NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING 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

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 Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161610EXPRT Revision Hip System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners

View all 31 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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