Cleared Traditional

K090845 - APEX ARC HIP STEM

K090845 is an FDA 510(k) clearance for APEX ARC HIP STEM, manufactured by Omni Life Science, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K090845

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
Combination Product No
PCCP Authorized No
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.

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 508
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