Cleared Traditional

K171559 - True Spinal Fixation System

K171559 is an FDA 510(k) clearance for True Spinal Fixation System, manufactured by Innovative Surgical Designs, 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.

K171559 · Innovative Surgical Designs, Inc. · Orthopedic device
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Jul 2017
Decision
55d
Days
Class 2
Risk

K171559 is an FDA 510(k) clearance for the True 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 Innovative Surgical Designs, Inc. (Bloomington, US). The FDA issued a Cleared decision on July 24, 2017 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 Innovative Surgical Designs, Inc. devices

FDA 510(k) Submission Details - K171559

510(k) Number K171559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2017
Decision Date July 24, 2017
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 716
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K171559.
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System
K172107 · Spineology, Inc. · Aug 2017
CapSure® PS System
K172175 · Spine Wave, Inc. · Aug 2017
M.U.S.T. Combined Set Screws
K171758 · Medacta International S.A. · Aug 2017
TiLock2 Spinal System
K171838 · Genesys Spine · Jul 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · L & K Biomed Co., Ltd. · Jul 2017
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
K170821 · Choicespine, LP · Jun 2017