Cleared Traditional

NOVEL FIT AND FILL STEM

K122853 · Howmedica Osteonics Corp. · Orthopedic

Feb 2013

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K122853 is an FDA 510(k) clearance for the NOVEL FIT AND FILL STEM, 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 February 1, 2013, 136 days after receiving the submission on September 18, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K122853 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2012
Decision Date	February 01, 2013
Days to Decision	136 days
Submission Type	Traditional
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