Cleared Special

KHEIRON? Spinal Fixation System, including patient specific K-ROD

K251804 · S.M.A.I.O · Orthopedic

Jul 2025

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K251804 is an FDA 510(k) clearance for the KHEIRON? Spinal Fixation System, including patient specific K-ROD, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by S.M.A.I.O (Saint Priest, FR). The FDA issued a Cleared decision on July 8, 2025, 26 days after receiving the submission on June 12, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K251804 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2025
Decision Date	July 08, 2025
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — 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.