EVOL Spinal Interbody System, EVOS Lumbar Interbody System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180891 FDA 510(k)
- FDA Product Code
- MAX 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 EVOL Spinal Interbody System and EVOS Lumbar Interbody System are intervertebral body devices designed for lumbar spine applications. These devices are intended for use in skeletally mature patients with degenerative disc disease, including up to Grade 1 spondylolisthesis at contiguous levels from L2 to S1, as classified under orthopedic spinal implant nomenclature.
The system is supplied as a sterile, single-use device and is approved for direct lateral interbody fusion procedures. Constructed with hydroxyapatite-enhanced PEEK-OPTIMA™ material, it offers osteoconductive properties and radiolucency while maintaining an elastic modulus comparable to cortical bone. Regulated under FDA 510(k) clearance (K180891), it is intended for use in surgical settings with appropriate sterile protocols.
Frequently asked questions
What types of surgical procedures is the EVOL Spinal Interbody System intended for, and why is this specific material choice important?
The EVOL Spinal Interbody System is specifically designed for direct lateral interbody fusion procedures in the lumbar spine (L2 to S1). It is constructed from hydroxyapatite-enhanced PEEK-OPTIMA™, a material that combines radiolucency (allowing clear X-ray imaging) with osteoconductive properties (promoting bone growth) while maintaining an elastic modulus close to cortical bone for better biomechanical compatibility. This makes it suitable for degenerative disc disease cases, including mild spondylolisthesis (Grade 1), where stability and integration with the spine are critical.
Is the EVOL system reusable, or is it meant for single-use only? How does this affect its handling and storage?
The EVOL Spinal Interbody System is sterile and intended for single-use only, as explicitly stated in the device description. This means each implant must be used once and discarded after surgery to maintain sterility and prevent cross-contamination. Clinicians should store the system in its original packaging until use and follow manufacturer-provided sterile handling protocols to ensure safety and efficacy during procedures.
What lumbar spine levels can the EVOL system be used for, and how does this differ from other interbody systems?
The EVOL system is approved for use at contiguous lumbar levels from L2 to S1, including patients with degenerative disc disease or up to Grade 1 spondylolisthesis. This range is broader than some traditional interbody systems, which may exclude upper lumbar levels (e.g., L1-L2) or have stricter spondylolisthesis limitations. The design is optimized for lateral access procedures, ensuring compatibility with minimally invasive techniques while addressing a wider spectrum of lumbar pathology.
How do I confirm the regulatory status of this device before purchasing or using it in my facility?
The EVOL Spinal Interbody System holds an FDA 510(k) clearance (K180891) under the Orthopedic advisory committee, classified as substantially equivalent (SESE) with a special clearance type. To verify its status, you can reference the FDA’s Premarket Notification Database (search by K-number) or contact the manufacturer, Cutting Edge Spine, LLC, at the provided address (101 Waxhaw Professional Park, Suite A, Waxhaw, NC 28173). Always ensure compliance with local institutional procurement and regulatory policies before 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: EVOL Spinal Interbody System, EVOS Lumbar Interbody System, Spinal Implant Systems | Cutting Edge Spine, EVOSha | Interbody System | Cutting Edge Spine
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180891 | Class II | Active |
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Manufacturer
- Manufacturer
- Cutting Edge Spine, LLC
Sources (1)
- FDA 510(k) K180891 24 fields · synced Sep 19, 2026