Trabecular Metal Vertebral Body Replacement (VBR), Model #06-115, 06-155
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070754 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 Trabecular Metal Vertebral Body Replacement (VBR) is a spinal implant classified as a vertebral body replacement device. It is designed to restore structural integrity and stability to damaged or collapsed vertebrae in the thoracolumbar spine (T1-L5) due to conditions such as trauma or tumor-related fractures.
This device is intended for surgical use in an operating room setting and is supplied sterile for single-patient use. It is regulated under FDA 510(k) clearance (K070754) as substantially equivalent to predicate devices, with no specific MRI safety labeling indicated. Models 06-115 and 06-155 are available for specific vertebral body sizes, and storage follows standard sterile orthopedic implant protocols.
Frequently asked questions
What specific spinal regions can the Trabecular Metal VBR be used to treat, and why is this important for surgical planning?
The Trabecular Metal VBR is designed for the thoracolumbar spine, covering vertebrae from T1 to L5. This targeted range is critical for surgical planning because it aligns with the most common sites for trauma or tumor-related vertebral collapse, ensuring the implant is anatomically appropriate for restoring structural integrity in those areas.
Are the Trabecular Metal VBR implants reusable, and if not, how should they be handled to maintain sterility before use?
The Trabecular Metal VBR is supplied sterile for single-patient use only, meaning each implant is intended for one surgical procedure. To maintain sterility, it must be stored according to standard sterile orthopedic implant protocols—typically in sealed, sterile packaging until immediately before use in the operating room.
What are the key differences between the Model 06-115 and Model 06-155, and how might a surgeon choose between them?
The models 06-115 and 06-155 are differentiated by their design to accommodate specific vertebral body sizes, though exact measurements are not provided in the data. A surgeon would select the appropriate model based on preoperative imaging (e.g., CT or MRI scans) to ensure the implant matches the patient’s anatomical dimensions, ensuring proper fit and stability during reconstruction.
How is the Trabecular Metal VBR regulated in the U.S., and what does the FDA’s clearance status imply for its use in clinical practice?
The Trabecular Metal VBR holds FDA 510(k) clearance (K070754), meaning it was determined to be substantially equivalent to a predicate device already on the market. This clearance implies that the device meets regulatory standards for safety and effectiveness as intended for vertebral body replacement in the thoracolumbar spine, though clinicians should always refer to the device labeling for specific surgical instructions and contraindications.
Can the Trabecular Metal VBR be used with MRI imaging, and if not, what alternatives should be considered?
The device data does not include MRI safety labeling, which suggests it may not be explicitly approved for MRI compatibility. If MRI imaging is required postoperatively, clinicians should consult the manufacturer’s instructions or alternative imaging modalities (e.g., CT scans) to avoid potential risks associated with metallic implants in magnetic fields.
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: Trabecular Metal Vertebral Body Replacement (Vbr), Model# 06-115, 06-155, Trabecular Metal Vertebral Body Replacement (Vbr), Model# 06-115, 06 ..., Trabecular Metal Vertebral Body Replacement (Vbr), Model# 06-115, 06-155, PDF Zimmer TMT Trabecular Metal Vertebral Body Replacement 5J{0 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070754 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Trabecular Metal Technology
Sources (1)
- FDA 510(k) K070754 24 fields · synced Sep 18, 2026