Cleared Traditional

DELTA SHOULDER

K021478 · Depuy, Inc. · Orthopedic

Nov 2003

Decision

559d

Days

Class 2

Risk

About This 510(k) Submission

K021478 is an FDA 510(k) clearance for the DELTA SHOULDER, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 18, 2003, 559 days after receiving the submission on May 8, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K021478 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2002
Decision Date	November 18, 2003
Days to Decision	559 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.