Cleared Traditional

K141327 - MINIMA S SYSTEM

K141327 is the FDA 510(k) clearance for MINIMA S SYSTEM by Lima Corporate S.P.A.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K141327 · Lima Corporate S.P.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2014
Decision
77d
Days
Class 2
Risk

K141327 is an FDA 510(k) clearance for the MINIMA S SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Fort Wayne, US). The FDA issued a Cleared decision on August 6, 2014 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lima Corporate S.P.A. devices

Submission Details

510(k) Number K141327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date August 06, 2014
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 K141327.
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235 · Microport Orthopedics, Inc. · Sep 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821 · Exactech, Inc. · Aug 2014
BIOLOX DELTA CERAMIC OPTION HEADS
K141653 · Biomet, Inc. · Aug 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674 · Exactech, Inc. · Jun 2014
MASTERSL FEMORAL STEM
K140975 · Lima Corporate S.P.A. · Jun 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K140676 · Microport Orthopedics, Inc. · May 2014