Cleared Special

K253802 - KHEIRON® Spinal Fixation System, including patient specific K-ROD

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

K253802 · S.M.A.I.O · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K253802

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 122d · This submission: 215d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

BioVera, Inc.
Robert A. Poggie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 873
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K253802.
Tiger 2 System
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