Cleared Abbreviated

K991162 - BIOLOX ALUMINA CERAMIC FEMORAL HEAD

K991162 is the FDA 510(k) clearance for BIOLOX ALUMINA CERAMIC FEMORAL HEAD by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Abbreviated 510(k) pathway after a 296-day FDA review.

K991162 · Smith & Nephew, Inc. · Orthopedic device
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Jan 2000
Decision
296d
Days
Class 2
Risk

K991162 is an FDA 510(k) clearance for the BIOLOX ALUMINA CERAMIC 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 Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on January 28, 2000 after a review of 296 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K991162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date January 28, 2000
Days to Decision 296 days
Submission Type Abbreviated
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
174d slower than avg
Panel avg: 122d · This submission: 296d
Pathway characteristics
Standards-based clearance path.

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 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K991162.
RESPONSE 2000 CEMENTED HIP STEM
K000432 · DePuy Orthopaedics, Inc. · Apr 2000
PLR SPLINED REVISION STEM
K994184 · Biomet, Inc. · Feb 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · Howmedica Osteonics Corp. · Feb 2000
MS-30 FEMORAL STEM
K993043 · Sulzer Orthopedics, Inc. · Dec 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
K992235 · Corin USA · Nov 1999
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
K990261 · Plus Orthopedics · Aug 1999