Cleared Special

K083762 - BIOLOX DELTA CERAMIC FEMORAL HEADS

K083762 is the FDA 510(k) clearance for BIOLOX DELTA CERAMIC FEMORAL HEADS by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 83-day FDA review.

K083762 · Smith & Nephew, Inc. · Orthopedic device
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Mar 2009
Decision
83d
Days
Class 2
Risk

K083762 is an FDA 510(k) clearance for the BIOLOX DELTA CERAMIC FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 11, 2009 after a review of 83 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K083762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2008
Decision Date March 11, 2009
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 429
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K083762.
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
K093846 · Zimmer, Inc. · Feb 2010
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K093944 · Medacta International S.A. · Jan 2010
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K093549 · Biomet Manufacturing Corp · Dec 2009
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K083558 · Medacta International S.A. · Mar 2009
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K082371 · Smith & Nephew, Inc. · Feb 2009
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K082996 · Biomet, Inc. · Jan 2009