Cleared Special

ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS (K051411) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051411 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2005
Decision
29d
Days
Class 2
Risk

K051411 is an FDA 510(k) clearance for the ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA 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 June 29, 2005 after a review of 29 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 Biomet, Inc. devices

Submission Details

510(k) Number K051411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2005
Decision Date June 29, 2005
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K051411.
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737 · Howmedica Osteonics Corp. · Jul 2005
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
BIOLOX DELTA CERAMIC HEADS
K042091 · Biomet, Inc. · Mar 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