Cleared Traditional

K052384 - LANX VBR SYSTEM

K052384 is an FDA 510(k) clearance for LANX VBR SYSTEM, manufactured by Lanx, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K052384 · Lanx, LLC · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K052384

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.

MQP Device Classification - Class 2, Special Controls

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 209
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052384.
KIMBA SPINAL IMPLANT
K052533 · Signus Medizintechnik GmbH · Nov 2005
CONCORDE VBR SPINAL SYSTEM
K052746 · Depuy Spine, Inc. · Oct 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
SEMIAL SPINAL IMPLANT
K051659 · Signus Medizintechnik GmbH · Jul 2005
MC+ PARTIAL VBR
K043479 · Ldr Spine USA · Jun 2005