Cleared Traditional

K152919 - OMNI Skirted Heads

K152919 is the FDA 510(k) clearance for OMNI Skirted Heads by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K152919 · Omni Life Science, Inc. · Orthopedic device
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Mar 2016
Decision
160d
Days
Class 2
Risk

K152919 is an FDA 510(k) clearance for the OMNI Skirted Heads. 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 March 10, 2016 after a review of 160 days - an extended review cycle.

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 Omni Life Science, Inc. devices

Submission Details

510(k) Number K152919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2015
Decision Date March 10, 2016
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
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 K152919.
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K151739 · Lima Corporate S.P.A. · Nov 2015
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K151531 · Medacta International · Oct 2015
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K151902 · Smith & Nephew, Inc. · Sep 2015