Cleared Special

K191145 - MasterLoc Extension

K191145 is the FDA 510(k) clearance for MasterLoc Extension by Medacta International S.A.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K191145 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
30d
Days
Class 2
Risk

K191145 is an FDA 510(k) clearance for the MasterLoc Extension. 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 S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on May 30, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medacta International S.A. devices

Submission Details

510(k) Number K191145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2019
Decision Date May 30, 2019
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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

Medacta USA
Chris Lussier

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 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K191145.
Corin Optimized Position System Functional Hip Analysis (OPS FHA)
K190834 · Corin USA · Jul 2019
Revival Modular Hip Stem
K191374 · Corin U.S.A. Limited · Jul 2019
Latitud Hip Replacement System
K183532 · Meril Healthcare Pvt. , Ltd. · Jul 2019
MobileLink Acetabular Cup System
K182321 · Waldemar Link GmbH & Co. KG · May 2019
Delta Dual Mobility System
K181491 · Lima Corporate S.P.A. · May 2019
Zimmer Biomet Ceramic Heads
K181171 · Zimmer, Inc. · Apr 2019