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Arisstos Spinal System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173126

by Ingenium Spine

Identifiers

510(k) Number
K173126 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 Arisstos Spinal System is a spinal fixation device classified as an orthopedic implant under the FDA’s product code NKB. It is designed to provide immobilization of spinal segments in skeletally mature patients, serving as an adjunct to spinal fusion for managing thoracic, lumbar, and sacral instabilities or deformities, including degenerative spondylolisthesis with neurological impairment.

This system is supplied as a reusable surgical implant and is intended for use in controlled clinical settings. It includes polyaxial screws, monoaxial screws, hooks, connectors, and anterior plates, with no indication of MRI compatibility or sterility requirements specified in the available data. The device holds a Traditional 510(k) clearance (K173126) under the FDA’s orthopedic advisory committee, with no third-party review noted.

Frequently asked questions

What types of spinal conditions is the Arisstos Spinal System intended to address in patients who have already reached skeletal maturity?

The Arisstos Spinal System is designed to stabilize spinal segments in skeletally mature patients as an adjunct to spinal fusion. It is specifically intended for managing instabilities or deformities in the thoracic, lumbar, and sacral regions, including cases of degenerative spondylolisthesis with neurological impairment. The system provides immobilization to support surgical outcomes in these areas.

Is the Arisstos Spinal System intended for single-use or can it be reused in multiple procedures?

The Arisstos Spinal System is explicitly described as a reusable surgical implant. This means it is engineered for use in controlled clinical settings where sterilization protocols can be followed between procedures, ensuring safe reuse.

What components are included in the Arisstos Spinal System, and how does this modularity benefit spinal surgery?

The system includes polyaxial screws, monoaxial screws, hooks, connectors, and anterior plates. This modularity allows surgeons to customize the fixation approach for different anatomical needs, improving stability and adaptability during thoracic, lumbar, or sacral procedures.

How was the Arisstos Spinal System evaluated for FDA clearance, and what does the Traditional 510(k) clearance indicate?

The Arisstos Spinal System received a Traditional 510(k) clearance (K173126) under the FDA’s orthopedic advisory committee (OR). This route means the manufacturer demonstrated that the device is *substantially equivalent* to a legally marketed predicate device, fulfilling FDA requirements for safety and effectiveness without third-party review involvement.

Are there any specific storage requirements or considerations for the Arisstos Spinal System before use in surgery?

The provided data does not specify sterility requirements or storage conditions for the Arisstos Spinal System. However, as a reusable implant, it must be stored in accordance with standard surgical instrument protocols to maintain cleanliness and prevent contamination before sterilization for use.

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. Sources consulted: Arisstos™ Spinal System (K173126) — FDA 510(k) | Innolitics, Ingenium Spine FDA 510 (k) Products - Latest 2024, Arisstos Spinal System - thespinemarketgroup.com, Home - Ingenium Spine - Advanced Spinal Technology

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ingenium Spine

Sources (1)

  • FDA 510(k) K173126 24 fields · synced Sep 19, 2026