Cleared Traditional

REUNION RSA SHOULDER SYSTEM

K130895 · Howmedica Osteonics Corp. · Orthopedic

Dec 2013

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K130895 is an FDA 510(k) clearance for the REUNION RSA SHOULDER SYSTEM, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on December 27, 2013, 270 days after receiving the submission on April 1, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K130895 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2013
Decision Date	December 27, 2013
Days to Decision	270 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.