Cleared Traditional

K133381 - OMNI ARC MONOBLOCK HIP STEM

K133381 is an FDA 510(k) clearance for OMNI ARC MONOBLOCK HIP STEM, manufactured by Omnilife Science. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K133381 · Omnilife Science · Orthopedic device
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Mar 2014
Decision
129d
Days
Class 2
Risk

K133381 is an FDA 510(k) clearance for the OMNI ARC MONOBLOCK HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Omnilife Science (East Taunton, US). The FDA issued a Cleared decision on March 13, 2014 after a review of 129 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 Omnilife Science devices

FDA 510(k) Submission Details - K133381

510(k) Number K133381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2013
Decision Date March 13, 2014
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 462
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K133381.
MASTERSL FEMORAL STEM
K140975 · Lima Corporate S.P.A. · Jun 2014
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
K140676 · Microport Orthopedics, Inc. · May 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
K140043 · Microport Orthopedics, Inc. · Apr 2014
CORIN METAFIX HIP STEM
K131952 · Corin USA · Dec 2013
CORIN MINIHIP STEM
K131986 · Corin USA · Dec 2013
MECTACER BIOLOX OPTION HEADS
K131518 · Medacta International · Nov 2013