Cleared Traditional

COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)

K152754 · Biomet Manufacturing Corp · Orthopedic

May 2016

Decision

235d

Days

Class 2

Risk

About This 510(k) Submission

K152754 is an FDA 510(k) clearance for the COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS), 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 May 16, 2016, 235 days after receiving the submission on September 24, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K152754 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2015
Decision Date	May 16, 2016
Days to Decision	235 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.