Cleared Traditional

LANX VBR SYSTEM (K052384) - FDA 510(k) Clearance

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

K052384 · Lanx, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
38d
Days
Class 2
Risk

K052384 is an FDA 510(k) clearance for the LANX VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Lanx, LLC (Pleasant Hill, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lanx, LLC devices

Submission Details

510(k) Number K052384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date October 07, 2005
Days to Decision 38 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 45
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052384.
RETAIN RADIOLUCENT SPACER
K061380 · Globus Medical, Inc. · Jun 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · Globus Medical, Inc. · May 2006
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004