Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223362 FDA 510(k)
- FDA Product Code
- OVE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cervical Spine Truss System - Stand Alone (CSTS-SA) is an interbody fusion device designed for spinal stabilization in the cervical spine. It employs a structural truss implant to support and maintain disc space height while facilitating fusion between adjacent vertebrae. This device is intended for use in skeletally mature patients with degenerative disc disease at one or two contiguous cervical levels. Its proprietary truss design aims to distribute mechanical load and promote a mechanobiologic response in surrounding tissue.
The CSTS-SA is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K223362) as a substantially equivalent orthopedic implant. It is intended for surgical use in spinal fusion procedures, requiring precise placement within the cervical intervertebral space. The device is packaged for one-time clinical application and must be handled according to sterile surgical protocols. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the specifications.
Frequently asked questions
What is the Cervical Spine Truss System - Stand Alone (CSTS-SA) used for?
The CSTS-SA is an interbody fusion device designed specifically for spinal stabilization in the cervical spine. It is intended for skeletally mature patients with degenerative disc disease at one or two contiguous cervical levels. The device’s proprietary truss design helps maintain disc space height and distribute mechanical load, which supports the fusion process between adjacent vertebrae.
How is the CSTS-SA supplied and prepared for use?
The CSTS-SA is supplied as a sterile, single-use device, meaning it is intended for one-time clinical application only. It must be handled according to strict sterile surgical protocols to ensure patient safety and device integrity. The packaging is designed for surgical use, requiring precise placement within the cervical intervertebral space during spinal fusion procedures.
Is the CSTS-SA reusable or intended for single-use?
The CSTS-SA is explicitly designed as a single-use device. This classification aligns with FDA 510(k) clearance requirements and ensures sterility and safety for each patient procedure. Reuse is not recommended or supported by the manufacturer.
What regulatory pathway does the CSTS-SA follow?
The CSTS-SA is regulated under the FDA’s 510(k) clearance pathway, specifically classified as substantially equivalent to existing orthopedic implants. It received clearance under K223362, confirming its compliance with FDA standards for spinal fusion devices. No additional regulatory approvals beyond this clearance are referenced.
How does the truss design of the CSTS-SA benefit patients?
The truss design of the CSTS-SA is engineered to distribute mechanical load across the cervical spine, reducing stress concentrations on adjacent vertebrae. This promotes a mechanobiologic response in surrounding tissues, which can enhance the fusion process by encouraging bone growth and stability. The design also helps maintain disc space height, supporting long-term spinal alignment.
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: Cervical Spine Truss System™ - Stand Alone - 4WEB, Cervical Spine Truss System™ - 4WEB - 4WEB Medical, Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223362 | Class II | Active |
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Manufacturer
- Manufacturer
- 4Web Medical, Inc.
Sources (1)
- FDA 510(k) K223362 24 fields · synced Oct 1, 2026