Cleared Traditional

K160289 - MasterLoc Stem

K160289 is the FDA 510(k) clearance for MasterLoc Stem by Medacta International. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K160289 · Medacta International · Orthopedic device
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May 2016
Decision
107d
Days
Class 2
Risk

K160289 is an FDA 510(k) clearance for the MasterLoc Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Medacta International (Castel San Pietro, CH). The FDA issued a Cleared decision on May 20, 2016 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medacta International devices

Submission Details

510(k) Number K160289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Mapi USA, Inc.
Roshana Ahmed

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K160289.
Zimmer M/L Taper Hip Prosthesis
K161830 · Zimmer, Inc. · Oct 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
K161192 · Zimmer GmbH · Jul 2016
Corin Optimized Positioning System (OPS)
K152893 · Corin USA · Jun 2016
REVIVAL(TM) Modular Revision Hip Stem
K152903 · Corin USA · Apr 2016
UCP Stem
K152530 · United Orthopedic Corporation · Mar 2016
Revision Femoral Stem
K151739 · Lima Corporate S.P.A. · Nov 2015