Cleared Special

KHEIRON® Spinal Fixation System, including patient specific K-ROD (K251804) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251804 · S.M.A.I.O · Orthopedic device
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Jul 2025
Decision
26d
Days
Class 2
Risk

K251804 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 8, 2025 after a review of 26 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. 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. Low regulatory complexity profile. 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 K251804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
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 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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K251804.
A8 INTEGR8™ Porous Pedicle Screws
K242827 · Allumin8, Inc. · Oct 2025
PressON Spinal Fixation System
K253331 · Nexus Spine · Oct 2025
JAZZ Spinal System
K252437 · Implanet · Aug 2025
Momentum® Posterior Spinal Fixation System
K251719 · Ulrich Medical USA, Inc. · Jul 2025
Virata Spinal Fixation System
K250908 · SeaSpine Orthopedics Corporation · Jun 2025
RIVA Posterior Fixation System
K251154 · Ht Medical D.B.A. Xenix Medical · Jun 2025