Cleared Traditional

QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES (K093692) - FDA 510(k) Clearance

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

K093692 · Pioneer Surgical Technology · Orthopedic device
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Aug 2010
Decision
254d
Days
Class 2
Risk

K093692 is an FDA 510(k) clearance for the QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES. 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 August 11, 2010 after a review of 254 days - an extended review cycle.

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 Pioneer Surgical Technology devices

Submission Details

510(k) Number K093692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2009
Decision Date August 11, 2010
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 403
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K093692.
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
CD HORIZON SPINAL SYSTEM
K102555 · Medtronic Sofamor Danek USA, Inc. · Nov 2010
SYNTHES MATRIX SYSTEM
K100634 · Synthes (Usa) · Jul 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · Medtronic Sofamor Danek USA, Inc. · Jun 2010
COCR RODS
K100788 · Globus Medical, Inc. · May 2010