Cleared Traditional

Inset Reverse Total Shoulder System

K252221 · Shoulder Innovations, Inc. · Orthopedic

Sep 2025

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K252221 is an FDA 510(k) clearance for the Inset Reverse Total Shoulder System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Shoulder Innovations, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 26, 2025, 72 days after receiving the submission on July 16, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K252221 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2025
Decision Date	September 26, 2025
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.