Cleared Traditional

ABG III MONOLITHIC HIP STEM

K123604 · Howmedica Osteonics Corp. · Orthopedic

Aug 2013

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K123604 is an FDA 510(k) clearance for the ABG III MONOLITHIC HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (Class II — Special Controls, product code MAY), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on August 16, 2013, 268 days after receiving the submission on November 21, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K123604 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2012
Decision Date	August 16, 2013
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAY — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353