Cleared Special

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

K253721 · S.M.A.I.O · Orthopedic

Dec 2025

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K253721 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 December 17, 2025, 23 days after receiving the submission on November 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K253721 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2025
Decision Date	December 17, 2025
Days to Decision	23 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.