Cleared Traditional

K131458 - MPACT DM LINER CONVERTER

K131458 is the FDA 510(k) clearance for MPACT DM LINER CONVERTER by Medacta International. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K131458 · Medacta International · Orthopedic device
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Oct 2013
Decision
134d
Days
Class 2
Risk

K131458 is an FDA 510(k) clearance for the MPACT DM LINER CONVERTER. 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 (Camarillo, US). The FDA issued a Cleared decision on October 1, 2013 after a review of 134 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 K131458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date October 01, 2013
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
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 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 K131458.
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · Smith & Nephew, Inc. · Oct 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728 · Smith & Nephew, Inc. · Oct 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684 · Biomet, Inc. · Oct 2013
TRINITY ACETABULAR SYSTEM
K131647 · Corin USA · Sep 2013
AVENIR CEMENTED HIP STEM
K131884 · Zimmer GmbH · Aug 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · Wrightmedicaltechnologyinc · Jul 2013