Cleared Special

ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS

K112556 · Howmedica Osteonics Corp. · Orthopedic

Sep 2011

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K112556 is an FDA 510(k) clearance for the ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on September 28, 2011, 26 days after receiving the submission on September 2, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K112556 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2011
Decision Date	September 28, 2011
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353