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FDA 510(k)

InSet Reverse Total Shoulder System

K-Number: K254128 · 2026-04-13

ApplicantShoulder Innovations, Inc.
Decision Date2026-04-13
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InSet Reverse Total Shoulder System is a medical device manufactured by Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2026-04-13 under approval number K254128. 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 InSet Reverse Total Shoulder System?

InSet Reverse Total Shoulder System is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Shoulder Innovations, Inc.. The 510(k) number is K254128.

When was InSet Reverse Total Shoulder System approved by the FDA?

InSet Reverse Total Shoulder System received FDA 510(k) clearance on 2026-04-13, under approval number K254128.

What company makes InSet Reverse Total Shoulder System?

InSet Reverse Total Shoulder System is manufactured by Shoulder Innovations, Inc..

What is the FDA product code for InSet Reverse Total Shoulder System?

The FDA product code for InSet Reverse Total Shoulder System is PHX.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

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: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Shoulder Innovations, Inc.

K173824Humeral Short Stem System K192365Shoulder Innovations Total Shoulder System K210533Inset Reverse Total Shoulder System K213615Shoulder Innovations Total Shoulder System K252221Inset Reverse Total Shoulder System K241817InSet Total Shoulder System

View all 8 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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