Cleared Special

K110692 - STREAMLINE TL SPINAL SYSTEM

K110692 is an FDA 510(k) clearance for STREAMLINE TL SPINAL SYSTEM, manufactured by Pioneer Surgical Technology, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 62-day FDA review.

K110692 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2011
Decision
62d
Days
Class 2
Risk

K110692 is an FDA 510(k) clearance for the STREAMLINE TL 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, Inc. (Marquette, US). The FDA issued a Cleared decision on May 12, 2011 after a review of 62 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, Inc. devices

FDA 510(k) Submission Details - K110692

510(k) Number K110692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2011
Decision Date May 12, 2011
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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 K110692.
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K110070 · Medtronic Sofamor Danck USA, Inc. · Jun 2011
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ISSYS LP SPINAL FIXATION SYSTEM
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K110216 · Depuy Spine, Inc. · Apr 2011
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K103237 · Lanx, Inc. · Mar 2011