Cleared Special

K111193 - APEX ARC HIP STEM

K111193 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 Special 510(k) pathway after a 60-day FDA review.

K111193 · Omni Life Science, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
60d
Days
Class 2
Risk

K111193 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. (East Taunton, US). The FDA issued a Cleared decision on June 27, 2011 after a review of 60 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111193

510(k) Number K111193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2011
Decision Date June 27, 2011
Days to Decision 60 days
Submission Type Special
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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K111193.
ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
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K110101 · Smith & Nephew, Inc. · Apr 2011
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K093736 · DePuy Orthopaedics, Inc. · Mar 2011
K111193 · APEX ARC HIP STEM
Download PDF FDA Summary Omni Life Science, In…