SpineFab Vertebral Body Replacement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142005 FDA 510(k)
- FDA Product Code
- MQP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SpineFab Vertebral Body Replacement System is a load-bearing implant designed as a replacement for a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1–L5). Manufactured from a polymer material, it is intended to restore structural integrity and support spinal alignment in cases of trauma, tumor, or degenerative conditions. The device is classified under orthopedic implants and is engineered to integrate with autograft or allograft bone graft material. Its primary function is to provide mechanical stability while facilitating biological incorporation over time.
This system is supplied sterile and intended for single-use in surgical settings. It requires supplemental fixation systems for proper placement and stabilization. The device is approved under FDA 510(k) clearance (K142005) as substantially equivalent to a predicate device, with no specific MRI safety restrictions noted. Available in sizes tailored to vertebral body dimensions, it is stored in a sterile packaging solution and intended for use by trained spinal surgeons in orthopedic procedures.
Frequently asked questions
What types of spinal conditions is the SpineFab Vertebral Body Replacement System intended to address in the thoracolumbar region?
The SpineFab VBR System is designed to address structural failures in the thoracolumbar spine (T1–L5) caused by trauma, tumors, or degenerative conditions that result in collapsed or unstable vertebral bodies. It replaces damaged segments to restore mechanical stability and support spinal alignment, integrating with bone graft material to promote biological incorporation over time.
How is the SpineFab System supplied, and what does this mean for surgical planning?
The SpineFab VBR System is supplied sterile and intended for single-use only, ensuring infection control in surgical settings. This means each implant is pre-packaged and ready for immediate use, eliminating the need for reprocessing. Clinicians should account for this in inventory planning, as each procedure requires a new, sterile unit.
Does the SpineFab System come in specific sizes, and how does this affect its compatibility with patients?
Yes, the SpineFab VBR System is available in sizes tailored to match the dimensions of individual vertebral bodies in the thoracolumbar spine (T1–L5). This customization allows for precise fitting to restore structural integrity, reducing the risk of improper placement or instability. Surgeons should select the appropriate size based on preoperative imaging to ensure optimal alignment and support.
What additional equipment or materials are required to use the SpineFab System during surgery?
The SpineFab VBR System requires supplemental fixation systems for proper placement and stabilization, as it is not self-stabilizing. This means additional hardware (e.g., screws, rods, or cages) may be needed to secure the implant in place. Surgeons should confirm compatibility with their preferred fixation methods before use.
How should the SpineFab System be stored, and what precautions should be taken to maintain its sterility?
The SpineFab VBR System is stored in sterile packaging, which preserves its sterility until use. To maintain integrity, storage should follow manufacturer guidelines—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile barrier should remain unbroken until the moment of surgical use to prevent 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: SpineFab Vertebral Body Replacement (VBR) System, PDF Microsoft Word - 003_5 SpineFab VBR 510(k) Summary 2015Jul09-1.docx, FDA Approves New 3D Printed Spine Implants
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142005 | Class II | Active |
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Manufacturer
- Manufacturer
- Oxford Performance Materials
Sources (1)
- FDA 510(k) K142005 24 fields · synced Sep 20, 2026