Cleared Traditional

H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS (K112091) - FDA 510(k) Clearance

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

K112091 · Lima Corporate S.P.A. · Orthopedic device
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Nov 2012
Decision
477d
Days
Class 2
Risk

K112091 is an FDA 510(k) clearance for the H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Winona Lake, US). The FDA issued a Cleared decision on November 9, 2012 after a review of 477 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Lima Corporate S.P.A. devices

Submission Details

510(k) Number K112091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2011
Decision Date November 09, 2012
Days to Decision 477 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
355d slower than avg
Panel avg: 122d · This submission: 477d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 103
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K112091.
Exactech® Novation® Element Press-fit Femoral Stem
K153649 · Exactech, Inc. · Aug 2016
DePuy Actis Duofox Hip Prosthesis
K150862 · DePuy Orthopaedics, Inc. · Sep 2015
NOVEL FIT AND FILL STEM
K122853 · Howmedica Osteonics Corp. · Feb 2013
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · Smith & Nephew, Inc. · Oct 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · Smith & Nephew, Inc. · Oct 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · Smith & Nephew, Inc. · Apr 2012