Cleared Traditional

K191575 - ARx Spinal System

K191575 is the FDA 510(k) clearance for ARx Spinal System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K191575 · Life Spine, Inc. · Orthopedic device
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Aug 2019
Decision
55d
Days
Class 2
Risk

K191575 is an FDA 510(k) clearance for the ARx 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 Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on August 8, 2019 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 Life Spine, Inc. devices

Submission Details

510(k) Number K191575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date August 08, 2019
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.

Device Classification

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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K191575.
mont blanc & mont blanc MIS Spinal Systems
K191726 · Spineway SA · Sep 2019
Curiteva Pedicle Screw System
K191810 · Curiteva, Inc. · Aug 2019
Facilis™ Spinal System
K191494 · Baui Biotech Co., Ltd. · Aug 2019
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
K191835 · Globus Medical, Inc. · Aug 2019
Elaris Pedicle Screw System
K183091 · Spinewelding AG · Aug 2019
4CIS® Chiron Spinal Fixation System
K190471 · Solco Biomedical Co., Ltd. · Jul 2019