Revolution Spinal Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163056 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 Revolution Spinal Fixation System is a monoaxial pedicle screw-based device designed for posterior spinal stabilization. It provides immobilization and spinal segment fixation in skeletally mature patients as an adjunct to spinal fusion, addressing thoracic and lumbar instabilities or deformities.
This system comprises screws of varying lengths and diameters paired with connector assemblies for secure attachment. It is intended for single-use in surgical settings and has received FDA 510(k) clearance under the Traditional pathway, classified under product code NKB. No third-party review was involved in its authorization.
Frequently asked questions
What types of spinal conditions is the Revolution Spinal Fixation System designed to address in skeletally mature patients?
The Revolution Spinal Fixation System is specifically designed for posterior spinal stabilization in skeletally mature patients to address thoracic and lumbar instabilities or deformities. It is intended as an adjunct to spinal fusion, providing immobilization and fixation for these regions.
How is the Revolution Spinal Fixation System supplied, and is it meant for single-use or reuse?
The Revolution Spinal Fixation System is supplied as a monoaxial pedicle screw-based device with screws of varying lengths and diameters paired with connector assemblies. It is explicitly intended for single-use in surgical settings, meaning each system is designed to be used once and then discarded.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its approval status?
The Revolution Spinal Fixation System received FDA clearance under the Traditional 510(k) pathway, classified under product code NKB (Orthopedic Devices). This means the manufacturer demonstrated that it is substantially equivalent to a legally marketed device already on the market, without involving a third-party review panel. The clearance was granted on February 24, 2017.
Are there different sizes or models available for the Revolution Spinal Fixation System, and how might that affect its use?
Yes, the system includes screws of varying lengths and diameters, which allows for customization based on the patient’s anatomy and surgical requirements. This flexibility ensures proper fixation in both thoracic and lumbar regions, accommodating different spinal segment sizes and stabilization needs.
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: Revolution Spinal Fixation System (K160216) — FDA 510(k) | Innolitics, Revolution Spinal Fixation System (K142939) — FDA 510 (k) | Innolitics, Revolution™ Spinal Fixation System 510(k) K163056 - FDA.report, Intelligent Implant Systems - thespinemarketgroup.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163056 | Class II | Active |
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Manufacturer
- Manufacturer
- Intelligent Implant Systems, Llc
Sources (1)
- FDA 510(k) K163056 24 fields · synced Sep 19, 2026