MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172212 FDA 510(k)
- FDA Product Code
- ODP 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 MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK is a spinal interbody fusion device designed for cervical spine applications. It is classified as an anterior cervical interbody fusion cage, intended to facilitate spinal stabilization and fusion in patients with degenerative disc disease. Constructed from a titanium-reinforced polyetheretherketone (Ti-PEEK) composite, the system provides structural support while promoting bone integration. Its design aims to accommodate varying cervical spine anatomies and reduce migration risks during fusion procedures.
The system is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K172212) as substantially equivalent to a predicate device. It is intended for use in orthopedic surgical settings, where it is implanted via an anterior approach to restore spinal alignment and promote fusion. Sizing and configuration options are tailored to cervical spine anatomy, and the device must be stored in accordance with manufacturer guidelines to maintain sterility. No MRI safety information is specified in the available data.
Frequently asked questions
What is the MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK used for?
The MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK is designed specifically for cervical spine applications to facilitate spinal stabilization and promote bone fusion in patients with degenerative disc disease. Its titanium-reinforced polyetheretherketone (Ti-PEEK) composite construction provides structural support while encouraging bone integration, helping restore spinal alignment through an anterior surgical approach.
How is the MATISSE Ti-PEEK cage system supplied and what are its sterility and reuse guidelines?
The MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining device integrity. Due to its single-use nature, reuse is not recommended or permitted, and each device must be used only once per patient.
What materials are used in the MATISSE Ti-PEEK cage system, and why is this combination important?
The system is constructed from a titanium-reinforced polyetheretherketone (Ti-PEEK) composite. The titanium reinforcement enhances structural stability, while PEEK promotes biocompatibility and bone integration. This combination reduces migration risks during fusion procedures and accommodates the anatomical variations of the cervical spine.
What sizing and configuration options are available for the MATISSE Ti-PEEK cage system?
The MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK offers sizing and configuration options tailored to the cervical spine anatomy. These variations ensure proper fit and alignment during implantation, improving the likelihood of successful fusion outcomes. Specific dimensions and configurations should be referenced in the manufacturer’s technical documentation.
How should the MATISSE Ti-PEEK cage system be stored to maintain sterility?
To maintain sterility, the MATISSE Anterior Cervical Interbody Fusion Cage System Ti-PEEK must be stored according to the manufacturer’s guidelines. This typically includes keeping the device in its original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage prevents contamination and ensures the device remains ready for single-use surgical procedures.
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: MATISSE™ - CTL Amedica, MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™, MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK by CTL ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172212 | Class II | Active |
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Manufacturer
- Manufacturer
- CTL Medical Corporation
Sources (1)
- FDA 510(k) K172212 24 fields · synced Oct 5, 2026