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Kheiron Spinal Fixation System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211414

by S.m.a.i.o

Identifiers

510(k) Number
K211414 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kheiron Spinal Fixation System is a spinal orthopedic device designed for internal fixation of the spine. It provides mechanical stability to the vertebral column through the use of screws, rods, and connecting hardware, aiding in the treatment of spinal deformities, fractures, or degenerative conditions requiring surgical intervention.

This system is supplied as a reusable surgical implant and is intended for use in operating room environments. It is classified under the product code NKB and is regulated under the Medical Device Directive (MDD) with FDA 510(k) clearance (K211414) for traditional review in the Orthopedic panel. Sterility and packaging details are not specified in the provided data.

Frequently asked questions

What types of spinal conditions is the Kheiron Spinal Fixation System designed to address in the operating room?

The Kheiron Spinal Fixation System is intended for internal fixation of the spine to provide mechanical stability during surgical treatment of spinal deformities, fractures, or degenerative conditions. It uses screws, rods, and connecting hardware to support the vertebral column, helping restore alignment and promote healing in complex cases.

Is the Kheiron Spinal Fixation System reusable or single-use, and how is it typically supplied for surgical use?

The Kheiron Spinal Fixation System is explicitly described as a reusable surgical implant. It is designed for use in operating room environments, though the specific packaging or sterility details (e.g., sterilization method or packaging type) are not provided in the data. Hospitals would follow their standard reprocessing protocols for reusable orthopedic implants.

What regulatory pathways has the Kheiron Spinal Fixation System followed for approval, and which advisory committee was involved?

The Kheiron Spinal Fixation System received FDA 510(k) clearance (K211414) under the traditional review process, with a determination of substantial equivalence to a predicate device. It was reviewed by the Orthopedic (OR) Advisory Committee and falls under the NKB product code for spinal fixation hardware. Additionally, it complies with the Medical Device Directive (MDD) in Europe.

What are the key components of the Kheiron Spinal Fixation System, and how do they work together?

The system consists of screws, rods, and connecting hardware that interlock to stabilize the spine. Screws anchor into vertebrae, while rods span multiple levels to maintain alignment, and connecting components (e.g., cross-links or adapters) secure the assembly. Together, these components provide rigid fixation to support healing in spinal deformities, fractures, or degenerative diseases requiring surgical intervention.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
S.m.a.i.o

Sources (2)

  • FDA 510(k) K211414 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026