Cleared Traditional

K130286 - STREAMLINE MIS SPINAL FIXATION SYSTEM

K130286 is an FDA 510(k) clearance for STREAMLINE MIS SPINAL FIXATION SYSTEM, manufactured by Pioneer Surgical Technology, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K130286 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Apr 2013
Decision
55d
Days
Class 2
Risk

K130286 is an FDA 510(k) clearance for the STREAMLINE MIS 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 Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on April 1, 2013 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pioneer Surgical Technology, Inc. devices

FDA 510(k) Submission Details - K130286

510(k) Number K130286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date April 01, 2013
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 890
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K130286.
INSTINCT JAVA SYSTEM
K123552 · Zimmer Spine · Apr 2013
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K130291 · Aesculap Implant System, Inc. · Apr 2013
CD HORIZON SPINAL SYSTEM
K130646 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130176 · Orthofix · Mar 2013
S4 SPINAL SYSTEM
K123939 · Aesculap Implant Systems, Inc. · Mar 2013
NAUTILUS SPINAL SYSTEM
K123373 · Life Spine · Mar 2013