Cleared Traditional

K143230 - Palladian Lumbar Pedicle Screw System

K143230 is the FDA 510(k) clearance for Palladian Lumbar Pedicle Screw System by Neurostructures, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K143230 · Neurostructures, Inc. · Orthopedic device
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Feb 2015
Decision
107d
Days
Class 2
Risk

K143230 is an FDA 510(k) clearance for the Palladian Lumbar Pedicle Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Neurostructures, Inc. (Irvine, US). The FDA issued a Cleared decision on February 25, 2015 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Neurostructures, Inc. devices

Submission Details

510(k) Number K143230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date February 25, 2015
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 615
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