Cleared Traditional

REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N

K103835 · Howmedica Osteonics Corp. · Orthopedic

May 2011

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K103835 is an FDA 510(k) clearance for the REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on May 5, 2011, 126 days after receiving the submission on December 30, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K103835 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2010
Decision Date	May 05, 2011
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660