Cleared Traditional

MPACT EXTENSION (K132879) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132879 · Medacta International · Orthopedic device
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Jan 2014
Decision
131d
Days
Class 2
Risk

K132879 is an FDA 510(k) clearance for the MPACT EXTENSION. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Medacta International (Camarillo, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 131 days - within the typical 510(k) review window.

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 devices

Submission Details

510(k) Number K132879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2013
Decision Date January 22, 2014
Days to Decision 131 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 122d · This submission: 131d
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 Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K132879.
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ALTEON 6.5MM BONE SCREWS
K141797 · Exactech, Inc. · Jul 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · DePuy Orthopaedics, Inc. · Mar 2014
ARCOS TROCHANTER BUTTON
K130063 · Biomet, Inc. · Apr 2013
SMITH & NEPHEW SMF HIP STEM
K123012 · Smith & Nephew, Inc. · Oct 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019 · Zimmer, Inc. · Oct 2012