Identifiers
- 510(k) Number
- K052406 FDA 510(k)
- FDA Product Code
- MNI 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 Uni-Thread Spinal System is a spinal fixation device classified as a spinal screw and rod system under the product code MNI. It consists of screws, rods, and connectors designed to stabilize the spine through internal fixation, addressing a range of spinal disorders via modular constructs.
This system is assembled in surgical settings using titanium alloy components compliant with ASTM F136 standards. It is intended for single-use and has received FDA 510(k) clearance under the Traditional pathway, with a clearance decision dated November 7, 2005. Components are available in various configurations to accommodate thoracolumbar spinal pathologies.
Frequently asked questions
What types of spinal conditions is the Uni-Thread Spinal System designed to address in clinical practice?
The Uni-Thread Spinal System is specifically designed to stabilize the thoracolumbar spine, which includes the lower thoracic and lumbar regions. It is intended for use in modular constructs to address spinal disorders in this area, such as degenerative diseases, deformities, or trauma requiring internal fixation. The modular nature of the system allows for customization to fit various anatomical needs within this region.
Is the Uni-Thread Spinal System reusable in the operating room, or is it intended for single-use only?
The Uni-Thread Spinal System is explicitly intended for single-use only. This is a standard practice for spinal fixation devices to ensure patient safety and sterility, as reusing implants could compromise integrity and introduce infection risks. The system’s titanium alloy components are manufactured to meet ASTM F136 standards, which align with single-use medical device guidelines.
What materials are used in the Uni-Thread Spinal System, and how does this affect its performance?
The Uni-Thread Spinal System is constructed entirely from titanium alloy components that comply with ASTM F136 standards. Titanium is commonly used in spinal implants due to its strength-to-weight ratio, corrosion resistance, and biocompatibility, which minimize the risk of adverse reactions in the body. This material choice ensures durability and stability during spinal fixation procedures while maintaining compatibility with the human body.
How is the Uni-Thread Spinal System supplied, and what variations in screw and rod configurations are available?
The Uni-Thread Spinal System is supplied as a modular kit containing screws, rods, and connectors tailored for thoracolumbar spinal applications. While the exact configurations are not detailed in the provided data, the system is designed to accommodate various modular constructs, allowing surgeons to assemble custom fixation solutions. This modularity ensures adaptability to different anatomical requirements and surgical approaches within the specified spinal region.
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: UNI-Thread® Versatile - SPINEMarketGroup, PDF K013301 - accessdata.fda.gov, UNI-THREAD SPINAL SYSTEM (K042640) — 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 | K052406 | Class II | Active |
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Manufacturer
- Manufacturer
- Spine Vision, Inc.
Sources (1)
- FDA 510(k) K052406 24 fields · synced Sep 19, 2026