Cleared Traditional

EXETER HIP STEM

K110290 · Howmedica Osteonics Corp. · Orthopedic
Sep 2011
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K110290 is an FDA 510(k) clearance for the EXETER HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on September 27, 2011, 238 days after receiving the submission on February 1, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K110290 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2011
Decision Date September 27, 2011
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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