Patriot Spinal Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180324 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 Patriot Spinal Fixation System is a small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation. It is designed to be screwed into the spine to hold a correction or stabilization device, such as a rod, plate, or tether, to bone. The device is made of a material that is not chemically degraded or absorbed via natural body processes, such as surgical steel or titanium alloy.
It is supplied as a sterile, single-use implant for use in the non-cervical posterior spine (T1 to S1) in skeletally mature patients as an adjunct to fusion. The device provides immobilization and stabilization of spinal segments in the treatment of acute and chronic instabilities or deformities, including degenerative spondylolisthesis. It is authorized under FDA 510(k) clearance (K180324) and classified as an orthopedic device with product code NKB.
Frequently asked questions
What is the Patriot Spinal Fixation System used for?
It is used for internal spinal fixation in the non-cervical posterior spine (T1 to S1) to hold correction or stabilization devices like rods, plates, or tethers to bone, providing immobilization and stabilization for acute or chronic instabilities or deformities such as degenerative spondylolisthesis, as an adjunct to fusion in skeletally mature patients.
Is the Patriot Spinal Fixation System sterile and single-use?
Yes, it is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and should not be reprocessed or reused to avoid risks of infection, material degradation, or mechanical failure.
What materials is the Patriot Spinal Fixation System made from?
The device is made of a material that is not chemically degraded or absorbed by natural body processes, such as surgical steel or titanium alloy, ensuring long-term structural integrity after implantation.
What spinal regions and patient types is the Patriot Spinal Fixation System intended for?
It is intended for use in the non-cervical posterior spine, specifically from T1 to S1, in skeletally mature patients as an adjunct to spinal fusion procedures.
How is the Patriot Spinal Fixation System implanted?
It is a small, threaded, implantable rod with a screw head and drive that is designed to be screwed directly into the spine to anchor stabilization devices such as rods, plates, or tethers to bone.
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: DEVICE: Patriot Spinal Fixation System (00811771032271), Patriot Spinal Fixation System — FDA Class I Medical Device | MedEquip ..., Patriot Spinal Fixation System (K180324) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180324 | Class II | Active |
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Manufacturer
- Manufacturer
- Valorus Spine
Sources (1)
- FDA 510(k) K180324 24 fields · synced Sep 28, 2026