Threshold V2 Pedicular Fixation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172107 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 Threshold V2 Pedicular Fixation System is a spinal fixation device designed for posterior, non-cervical skeletal stabilization. It consists of titanium alloy pedicle screws, curved and straight rods, and ConneX Connectors, enabling customizable construct assembly to address anatomical variations in skeletally mature patients.
This system is supplied sterile and intended for single-use in orthopedic surgical procedures. Components include screws (diameters and materials specified per configuration), rods (with defined diameters and materials), and connectors (configurations detailed in manufacturer documentation). The device is regulated under FDA 510(k) clearance (K172107) and falls under the Orthopedic Advisory Committee classification, adhering to traditional review standards.
Frequently asked questions
What types of spinal procedures is the Threshold V2 Pedicular Fixation System designed for, and what anatomical regions does it target?
The Threshold V2 Pedicular Fixation System is specifically designed for posterior spinal stabilization in skeletally mature patients, excluding the cervical spine. It is intended for procedures requiring secure fixation to address anatomical variations, such as deformity correction, fracture stabilization, or degenerative disease management in the thoracic and lumbar regions.
Is the Threshold V2 Pedicular Fixation System intended for reuse, or is it meant to be used only once during surgery?
The system is explicitly supplied sterile and intended for single-use only in orthopedic surgical procedures. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.
What materials are used in the Threshold V2 Pedicular Fixation System, and how does this affect its compatibility with other implants?
The system primarily features titanium alloy components, including screws, rods, and connectors. Titanium is biocompatible and corrosion-resistant, making it suitable for long-term fixation and reducing the risk of adverse reactions. The use of titanium also ensures compatibility with other titanium-based implants, minimizing galvanic corrosion risks when paired with similar materials.
How are the rods and screws configured in the Threshold V2 Pedicular Fixation System, and what flexibility does this offer during surgery?
The system includes both curved and straight rods, along with pedicle screws of varying diameters and configurations, allowing for customizable construct assembly. This flexibility accommodates anatomical variations in the spine, enabling surgeons to tailor the fixation to the patient’s specific needs, whether for alignment correction, load-sharing, or segmental stabilization.
What regulatory pathway was followed for the Threshold V2 Pedicular Fixation System, and which advisory committee reviewed its submission?
The device was cleared through the FDA 510(k) pathway under Traditional Review, with a clearance number of K172107. The submission was reviewed by the Orthopedic Advisory Committee (OR), which evaluates spinal fixation devices under the product code NKB to ensure safety and effectiveness for its intended 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: PDF FortressTM Pedicular Fixation System ThresholdTM Pedicular Fixation ..., Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation ..., Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172107 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K172107 24 fields · synced Oct 6, 2026