Cleared Traditional

K170710 - True Spinal Fixation System

K170710 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 128-day FDA review.

K170710 · Innovative Surgical Designs, Inc. · Orthopedic device
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Jul 2017
Decision
128d
Days
Class 2
Risk

K170710 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 14, 2017 after a review of 128 days - within the typical 510(k) review window.

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 Innovative Surgical Designs, Inc. devices

FDA 510(k) Submission Details - K170710

510(k) Number K170710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2017
Decision Date July 14, 2017
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 K170710.
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
Palisade™ Pedicular Fixation System
K171438 · Spineology, Inc. · Jun 2017