OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 mor…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250213 FDA 510(k)
- FDA Product Code
- GXI FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4725 FDA 510(k)
- Regulation Number
- 882.4725 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OptaBlate BVN Intraosseous Nerve Ablation System is a Probe, Radiofrequency Lesion device designed for intraosseous nerve ablation. It delivers controlled radiofrequency energy to target and ablate basivertebral nerves within the vertebral bodies, intended for use in the L3 through S1 vertebrae to address chronic back pain associated with these nerves. The system employs a precise 10mm probe to create targeted lesions, reducing nerve signaling that contributes to pain.
The system is supplied as either a single or dual kit, each containing the 10mm probe and associated components for single or paired nerve ablation procedures. It is intended for single-use and requires sterile handling in a clinical setting. The device has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (regulation number 882.4725). No specific MRI safety information is provided, and storage conditions align with standard sterile medical device protocols.
Frequently asked questions
What is the OptaBlate BVN system used for?
The OptaBlate BVN Intraosseous Nerve Ablation System is designed to deliver controlled radiofrequency energy to ablate basivertebral nerves within vertebral bodies (L3 through S1). This procedure targets chronic back pain caused by these nerves, aiming to reduce nerve signaling that contributes to discomfort. It is specifically intended for intraosseous (within the bone) nerve ablation.
How is the OptaBlate BVN system supplied, and what does each kit include?
The system is available as either a single kit or a dual kit, both featuring the 10mm probe. The single kit is configured for one nerve ablation procedure, while the dual kit allows for paired nerve ablation in a single session. Each kit includes the probe and all associated components required for the respective procedure type.
Is the OptaBlate BVN system single-use or reusable?
The OptaBlate BVN system is intended for single-use only. This design ensures sterility and safety for each procedure, as reuse could compromise device integrity or introduce infection risks. Sterile handling in a clinical setting is mandatory.
What storage conditions apply to the OptaBlate BVN system?
Storage follows standard protocols for sterile medical devices. The system should be kept in a clean, dry environment, protected from physical damage or contamination. Avoid exposure to extreme temperatures or moisture. Adhere to manufacturer guidelines for packaging integrity and expiration dates.
Does the OptaBlate BVN system have any MRI safety information?
No specific MRI safety information is provided for the OptaBlate BVN system. Clinicians should consult the device labeling and follow institutional MRI safety protocols to ensure compatibility with imaging environments, particularly if residual components remain in the patient.
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: OptaBlate® basivertebral nerve ablation system | Stryker, OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit ..., OptaBlate Nerve Ablation | Medical Device Navigator, PDF Stryker Instruments Dayana Manganese Staff Specialist, Regulatory ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250213 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K250213 24 fields · synced Oct 1, 2026