Cleared Traditional

K171966 - Mpact 3D Metal Implants and Augments 3D...

K171966 is the FDA 510(k) clearance for Mpact 3D Metal Implants and Augments 3D... by Medacta International S.A.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K171966 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
270d
Days
Class 2
Risk

K171966 is an FDA 510(k) clearance for the Mpact® 3D Metal™ Implants and Augments 3D Metal™. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on March 27, 2018 after a review of 270 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 S.A. devices

Submission Details

510(k) Number K171966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date March 27, 2018
Days to Decision 270 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
148d slower than avg
Panel avg: 122d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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.
Elizabeth Rose

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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K171966.
Prime Acetabular Cup System
K180798 · Microport Orthopedics, Inc. · Jul 2018
Trinity PLUS Acetabular Shell
K172551 · Corin U.S.A. Limited · Jun 2018
Legend Acetabular Liners
K173951 · Ortho Development Corporation · May 2018
Bone Screws 6.5mm
K172456 · Lima Corporate S.P.A. · Jan 2018
Birmingham Hip (BH) Dual Mobility Insert
K171934 · Smith & Nephew, Inc. · Nov 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · Smith & Nephew, Inc. · Nov 2017