Cleared Special

K080518 - PIONEER SURGICAL TECHNOLOGY QUANTUM SPI...

K080518 is the FDA 510(k) clearance for PIONEER SURGICAL TECHNOLOGY QUANTUM SPI... by Pioneer Surgical Technology. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 24-day FDA review.

K080518 · Pioneer Surgical Technology · Orthopedic device
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Mar 2008
Decision
24d
Days
Class 2
Risk

K080518 is an FDA 510(k) clearance for the PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 24 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 Pioneer Surgical Technology devices

Submission Details

510(k) Number K080518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date March 20, 2008
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K080518.
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
K080928 · Stryker Spine · Apr 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K073364 · Depuy Spine, Inc. · Apr 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K080504 · Pioneer Surgical Technology · Mar 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K080258 · Endius, Inc. · Mar 2008
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510 · Endius, Inc. · Feb 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · Endius, Inc. · Jan 2008