Cleared Traditional

DePuy Synthes Femoral Neck System

K172872 · DePuy Synthes · Orthopedic

Mar 2018

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K172872 is an FDA 510(k) clearance for the DePuy Synthes Femoral Neck System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by DePuy Synthes (Zuchwil, CH). The FDA issued a Cleared decision on March 5, 2018, 165 days after receiving the submission on September 21, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K172872 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2017
Decision Date	March 05, 2018
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030