Cleared Traditional

POROUS COATED COMPREHENSIVE FRACTURE STEMS

K140652 · Biomet Manufacturing Corp · Orthopedic

Jul 2014

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K140652 is an FDA 510(k) clearance for the POROUS COATED COMPREHENSIVE FRACTURE STEMS, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 3, 2014, 111 days after receiving the submission on March 14, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K140652 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2014
Decision Date	July 03, 2014
Days to Decision	111 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.