Cleared Special

Fitmore Hip Stem

K192236 · Zimmer GmbH · Orthopedic

Nov 2019

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K192236 is an FDA 510(k) clearance for the Fitmore Hip Stem, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on November 5, 2019, 78 days after receiving the submission on August 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K192236 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2019
Decision Date	November 05, 2019
Days to Decision	78 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390