Cleared Special

K101451 - APEX MODULE HIP SYSTEM BIOLOX DELTA FEM...

K101451 is the FDA 510(k) clearance for APEX MODULE HIP SYSTEM BIOLOX DELTA FEM... by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 28-day FDA review.

K101451 · Omni Life Science, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
28d
Days
Class 2
Risk

K101451 is an FDA 510(k) clearance for the APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD. 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 22, 2010 after a review of 28 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.

View all Omni Life Science, Inc. devices

Submission Details

510(k) Number K101451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2010
Decision Date June 22, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K101451.
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
K103012 · Exactech, Inc. · Nov 2010
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
K102487 · Exactech, Inc. · Nov 2010
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
K101296 · Zimmer, Inc. · Jul 2010
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