Cleared Special

K253802 - KHEIRON Spinal Fixation System

K253802 is the FDA 510(k) clearance for KHEIRON Spinal Fixation System by S.M.A.I.O. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 215-day FDA review.

K253802 · S.M.A.I.O · Orthopedic device
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Jul 2026
Decision
215d
Days
Class 2
Risk

K253802 is an FDA 510(k) clearance for the KHEIRON® Spinal Fixation System, including patient specific K-ROD. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by S.M.A.I.O (Saint-Priest, FR). The FDA issued a Cleared decision on July 1, 2026 after a review of 215 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all S.M.A.I.O devices

Submission Details

510(k) Number K253802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date July 01, 2026
Days to Decision 215 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 122d · This submission: 215d
Pathway characteristics
Modification to existing cleared device.

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 650
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K253802.
Invictus® Small Stature Spinal Fixation System
K261284 · Alphatec Spine, Inc. · Jul 2026
Varion Thoracolumbar Fixation System
K260989 · Kyocera Medical Technologies Inc. (KMTI) · May 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System
K253739 · Globus Medical, Inc. · May 2026
AccelFix Spinal Fixation System
K261130 · L & K Biomed Co., Ltd. · May 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · May 2026
LEO Spinal System
K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026