Cleared Traditional

K101790 - QUANTUM SPINAL SYSTEM

K101790 is the FDA 510(k) clearance for QUANTUM SPINAL SYSTEM by Pioneer Surgical Technology. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K101790 · Pioneer Surgical Technology · Orthopedic device
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Mar 2011
Decision
252d
Days
Class 2
Risk

K101790 is an FDA 510(k) clearance for the QUANTUM SPINAL SYSTEM, QUANTUM MIS. 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 (West Newbury, US). The FDA issued a Cleared decision on March 7, 2011 after a review of 252 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 K101790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date March 07, 2011
Days to Decision 252 days
Submission Type Traditional
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
130d slower than avg
Panel avg: 122d · This submission: 252d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K101790.
TSRH SPINAL SYSTEM
K110676 · Medtronic Sofamor Danek · May 2011
EXPEDIUM SYSTEM, VIPER SYSTEM
K110216 · Depuy Spine, Inc. · Apr 2011
REVERE SACRAL PLATES
K103072 · Globus Medical, Inc. · Mar 2011
TRIO TRAUMA SPINAL SYSTEM
K103292 · Stryker Corporation · Mar 2011
VEPER SYSTEM, EXPEDIUM SYSTEM
K103133 · Depuy Spine, Inc. · Jan 2011
SYNTHES 6.0 COCR AND CPT TI-3 RODS
K103287 · Synthes Spine · Jan 2011