Cleared Traditional

INHANCE? Reverse Shoulder System

K253624 · Depuy Ireland UC · Orthopedic

Mar 2026

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K253624 is an FDA 510(k) clearance for the INHANCE? Reverse Shoulder System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on March 11, 2026, 113 days after receiving the submission on November 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K253624 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2025
Decision Date	March 11, 2026
Days to Decision	113 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.