Cleared Traditional

INHANCETM Shoulder System ? Humeral Stems and Stemless

K223211 · Depuy Ireland UC · Orthopedic

Dec 2022

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K223211 is an FDA 510(k) clearance for the INHANCETM Shoulder System ? Humeral Stems and Stemless, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on December 2, 2022, 46 days after receiving the submission on October 17, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K223211 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2022
Decision Date	December 02, 2022
Days to Decision	46 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.