Cleared Traditional

K090845 - APEX ARC HIP STEM

K090845 is the FDA 510(k) clearance for APEX ARC HIP STEM by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K090845 · Omni Life Science, Inc. · Orthopedic device
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Apr 2010
Decision
376d
Days
Class 2
Risk

K090845 is an FDA 510(k) clearance for the APEX ARC 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 Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on April 7, 2010 after a review of 376 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Omni Life Science, Inc. devices

Submission Details

510(k) Number K090845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2009
Decision Date April 07, 2010
Days to Decision 376 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
254d slower than avg
Panel avg: 122d · This submission: 376d
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 434
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K090845.
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412 · Smith & Nephew, Inc. · May 2010
PROFEMUR HIP SYSTEM MODULAR NECKS
K100866 · Wrightmedicaltechnologyinc · Apr 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
K093991 · Smith & Nephew, Inc. · Apr 2010
MINIHIP STEM
K083312 · Corin USA · Apr 2010
CORIN METAFIX FEMORAL STEM
K082525 · Corin USA · Feb 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
K093846 · Zimmer, Inc. · Feb 2010