Cleared Traditional

MasterLoc Stem

K151531 · Medacta International · Orthopedic

Oct 2015

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K151531 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 October 30, 2015, 144 days after receiving the submission on June 8, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K151531 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2015
Decision Date	October 30, 2015
Days to Decision	144 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