Cleared Traditional

BIOLOX DELTA CERAMIC HEADS (K042091) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042091 · Biomet, Inc. · Orthopedic device
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Mar 2005
Decision
234d
Days
Class 2
Risk

K042091 is an FDA 510(k) clearance for the BIOLOX DELTA CERAMIC HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 25, 2005 after a review of 234 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 Biomet, Inc. devices

Submission Details

510(k) Number K042091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2004
Decision Date March 25, 2005
Days to Decision 234 days
Submission Type Traditional
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
112d slower than avg
Panel avg: 122d · This submission: 234d
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 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K042091.
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738 · Howmedica Osteonics Corp. · Jul 2005
BIOLOX DELTA CERAMIC FEMORAL HEADS
K051588 · Howmedica Osteonics Corp. · Jul 2005
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
K051411 · Biomet, Inc. · Jun 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
K041940 · Howmedica Osteonics Corp. · Feb 2005
CORAIL AMT HIP PROSTHESIS
K042992 · DePuy Orthopaedics, Inc. · Feb 2005
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · Howmedica Osteonics Corp. · Nov 2004