Cleared Traditional

K172469 - TiLock Modular Spinal System

K172469 is an FDA 510(k) clearance for TiLock Modular Spinal System, manufactured by Genesys Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K172469 · Genesys Spine · Orthopedic device
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Nov 2017
Decision
107d
Days
Class 2
Risk

K172469 is an FDA 510(k) clearance for the TiLock Modular 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 Genesys Spine (Austin, US). The FDA issued a Cleared decision on November 30, 2017 after a review of 107 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 Genesys Spine devices

FDA 510(k) Submission Details - K172469

510(k) Number K172469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2017
Decision Date November 30, 2017
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 888
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K172469.
CorticaLINK Spinal Fusion Platform
K173484 · Linkspine, Inc. · Dec 2017
Rexious Spinal Fixation System
K173131 · Huvexel Co. , Ltd. · Dec 2017
Arisstos™ Spinal System
K173126 · Ingenium Spine · Dec 2017
Solanas® Posterior Stabilization System
K173522 · Alphatec Spine, Inc. · Nov 2017
CosmoLock Pedicle Screw System
K172808 · Kalitec Direct, LLC · Oct 2017
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
K173095 · Medos International SARL · Oct 2017