VySpan PCT System
FDA 510(k)Class II (US FDA 510(k))
by Vy Spine Llc
Identifiers
- 510(k) Number
- K223852 FDA 510(k)
- FDA Product Code
- NKG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3075 FDA 510(k)
- Regulation Number
- 888.3075 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VySpan PCT System is a posterior cervical-thoracic spinal fixation device designed for orthopedic use. It provides stabilization and support to the spine through a modular assembly of screws, hooks, rods, and connectors, facilitating spinal fusion procedures in the cervical and thoracic regions. The system includes polyaxial and fixed-angle heads, enabling versatile surgical applications tailored to patient anatomy and clinical needs.
This system is supplied sterile and intended for single-use in clinical settings, including operating rooms and surgical suites. Components are manufactured to comply with FDA 510(k) clearance (K223852) under the orthopedic advisory committee, ensuring regulatory adherence. The modular design accommodates various screw types (hooks, standard-thread screws, smooth-shank screws) and rod configurations, with no MRI safety restrictions specified. Storage requires adherence to sterile packaging protocols as per manufacturer guidelines.
Frequently asked questions
What is the VySpan PCT System used for?
The VySpan PCT System is designed for posterior cervical-thoracic spinal fixation, providing stabilization and support during spinal fusion surgeries in the cervical and thoracic regions. Its modular components—including polyaxial and fixed-angle screws, hooks, rods, and connectors—allow surgeons to tailor the system to individual patient anatomy and clinical requirements.
How is the VySpan PCT System supplied and intended for use?
The VySpan PCT System is supplied sterile and intended exclusively for single-use in clinical settings such as operating rooms and surgical suites. This ensures compliance with sterile field protocols and minimizes the risk of contamination or cross-infection.
What types of screws and rods are included in the VySpan PCT System?
The system includes a variety of screws such as hooks, standard-thread screws, and smooth-shank screws, along with modular rods. This versatility allows for customization based on surgical needs, patient anatomy, and the specific demands of cervical-thoracic stabilization procedures.
Is the VySpan PCT System compatible with MRI imaging?
The VySpan PCT System does not specify any MRI safety restrictions in its documentation. However, clinicians should verify compatibility with their specific MRI equipment and protocols before use, as MRI safety depends on the materials and construction of the device.
How should the VySpan PCT System be stored?
The VySpan PCT System must be stored according to the manufacturer’s sterile packaging guidelines to maintain sterility. This includes keeping the components in their original, unopened packaging until ready for use and ensuring the environment is clean and free from contamination.
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: VySpan™ PCT System - vyspine.com, FDA Clearance of VySpan™ PCT System - vyspine.com, Vy Spine VySpan PCT System (K213394) — 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 | K223852 | Class II | Active |
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Manufacturer
- Manufacturer
- Vy Spine Llc
- FDA Applicant
- Vy Spine, LLC
Sources (1)
- FDA 510(k) K223852 24 fields · synced Oct 1, 2026