Cleared Traditional

MasterLoc Stem

K160289 · Medacta International · Orthopedic

May 2016

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K160289 is an FDA 510(k) clearance for the MasterLoc Stem, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Medacta International (Castel San Pietro, CH). The FDA issued a Cleared decision on May 20, 2016, 107 days after receiving the submission on February 3, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K160289 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2016
Decision Date	May 20, 2016
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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