Cleared Traditional

K132879 - MPACT EXTENSION

K132879 is an FDA 510(k) clearance for MPACT EXTENSION, manufactured by Medacta International. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 131-day FDA review.

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

FDA 510(k) Submission Details - K132879

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
Combination Product No
PCCP Authorized No
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.

LPH Device Classification - Class 2, Special Controls

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 542
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K132879.
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ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
K133228 · Iconacy Orthopedic Implants, LLC · Jan 2014
OVATION 10/12 HIP STEM
K131022 · Ortho Development Corp. · Oct 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K132626 · Pipeline Biotechnology · Sep 2013