Cleared Traditional

K131458 - MPACT DM LINER CONVERTER

K131458 is an FDA 510(k) clearance for MPACT DM LINER CONVERTER, manufactured by Medacta International. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K131458

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.

LZO Device Classification - Class 2, Special Controls

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 509
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
U-MOTION II PS+ CUP
K132455 · United Orthopedic Corp. · Sep 2013
AVENIR CEMENTED HIP STEM
K131884 · Zimmer GmbH · Aug 2013