Rhausler Plage Anterior Cervical Fusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111272 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 Rhausler Plage Anterior Cervical Fusion System is a one-piece plate-cage implant classified as an anterior cervical spinal fusion device. It combines a plate and cage into a single titanium construct, designed to stabilize the cervical spine from levels C3 through C7 by providing immediate fixation and acting as a disc spacer for bone graft placement.
This device is intended for single-level anterior cervical spinal fusion procedures and is supplied sterile for surgical use. Constructed from roughened titanium, it integrates fixation by direct purchase into vertebral endplates, with large bone graft viewing holes to facilitate graft placement. The system is cleared by the FDA under 510(k) number K111272 as substantially equivalent to a predicate device, adhering to orthopedic spinal fusion standards.
Frequently asked questions
What cervical spine levels is this device designed to address and how does it provide stability?
The Rhausler Plage Anterior Cervical Fusion System is specifically designed for single-level anterior cervical spinal fusion procedures between vertebral levels C3 through C7. It achieves stability through a one-piece titanium plate-cage construct that integrates direct fixation into the vertebral endplates, eliminating the need for separate screws. The roughened titanium surface enhances osseointegration, while the integrated cage serves as a disc spacer to support bone graft placement, promoting fusion.
Is this device intended for reuse in surgery, or is it meant to be used once and then discarded?
The Rhausler Plage Anterior Cervical Fusion System is supplied sterile for surgical use and is intended for single-use only. Once implanted, it remains permanently in the patient’s body as part of the spinal fusion procedure, so it is not designed for reuse.
What materials is the device made from, and how does that affect its performance?
The device is constructed entirely from roughened titanium, which provides a textured surface to enhance direct purchase into the vertebral endplates. This material choice improves osseointegration—meaning it encourages bone growth and fusion—while also offering biocompatibility and structural integrity for long-term stability in the cervical spine.
How is the bone graft placement facilitated during surgery with this system?
The system includes large bone graft viewing holes in the cage portion of the implant, allowing surgeons direct visualization and access to place bone graft material. This design ensures proper positioning of the graft within the fusion site, optimizing conditions for successful spinal fusion.
What are the key differences between this device and traditional anterior cervical fusion systems?
Unlike traditional systems that require separate cages and plates with additional screws, the Rhausler Plage system combines the cage and plate into a single titanium construct. This eliminates the need for multiple components and screws, simplifying implantation while maintaining immediate fixation and serving as a disc spacer for bone graft placement—all within a one-piece design.
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: Rhausler Inc. - Advanced Spine Implants, The PLAGE™ Anterior Cervical Fusion System - Rhausler Inc., PLAGE Anterior Cervical Fusion System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111272 | Class II | Active |
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Manufacturer
- Manufacturer
- Rhausler, Inc.
Sources (1)
- FDA 510(k) K111272 24 fields · synced Sep 19, 2026