Cleared Special

K120399 - LANX SPINAL FIXATION SYSTEM

K120399 is an FDA 510(k) clearance for LANX SPINAL FIXATION SYSTEM, manufactured by Lanx, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 30-day FDA review.

K120399 · Lanx, LLC · Orthopedic device
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Mar 2012
Decision
30d
Days
Class 2
Risk

K120399 is an FDA 510(k) clearance for the LANX SPINAL FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Lanx, LLC (Broomfield, US). The FDA issued a Cleared decision on March 9, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Lanx, LLC devices

FDA 510(k) Submission Details - K120399

510(k) Number K120399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2012
Decision Date March 09, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 747
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K120399.
VIPER SYSTEM
K121020 · Depuy Spine, Inc. · May 2012
TIGER SPINE SYSTEM
K113058 · Corelink, LLC · Mar 2012
VENUS SPINAL FIXATION SYSTEM
K120270 · L & K Biomed Co., Ltd. · Mar 2012
POWER ADAPTOR INSTRUMENT ACCESSORY
K120434 · Stryker Corp. · Mar 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · Orthofix, Inc. · Feb 2012
FOCUS SPINAL SYSTEM
K120140 · L & K Biomed Co., Ltd. · Feb 2012