ClearPoint Bone Screw Fiducials
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233144 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ClearPoint Bone Screw Fiducials are a type of Fiducial Marker, Bone (per nomenclature authority definitions), designed to provide precise anatomical reference points during neurosurgical procedures. These fiducials are screw-type markers that attach to bone surfaces, enabling accurate spatial mapping and alignment for image-guided interventions, such as stereotactic biopsies or tumor resections.
Supplied as a sterile, single-use device, the ClearPoint Bone Screw Fiducials are intended for intraoperative use in MRI-compatible and non-MRI environments. Each set includes screws of varying sizes (as specified in the product documentation) and is regulated under FDA 510(k) clearance (K233144) and EU MDR compliance. Storage requires protection from contamination and extreme temperatures, adhering to standard sterile medical device handling protocols.
Frequently asked questions
What clinical procedures are these fiducials primarily used for during neurosurgery?
These fiducials are designed to provide precise anatomical reference points for image-guided neurosurgical interventions, such as stereotactic biopsies or tumor resections. By attaching to bone surfaces, they enable accurate spatial mapping and alignment, which is critical for guiding instruments with high precision in real-time.
Are these fiducials compatible with MRI environments, and if so, how does that affect their use?
Yes, the ClearPoint Bone Screw Fiducials are explicitly labeled for use in both MRI-compatible and non-MRI environments. This dual-compatibility ensures they can be utilized in procedures requiring imaging guidance without interference, making them versatile for a range of intraoperative scenarios.
How are these fiducials supplied, and what should I consider when storing them?
They are supplied as a sterile, single-use device in sets containing screws of varying sizes (specifications detailed in the product documentation). Storage requires protection from contamination and extreme temperatures, following standard sterile medical device protocols to maintain integrity until use.
What regulatory pathways have these fiducials undergone, and how does that impact their adoption?
The ClearPoint Bone Screw Fiducials have undergone FDA 510(k) clearance (K233144) and comply with EU MDR requirements, confirming their safety and performance against established standards. This regulatory route ensures they meet stringent criteria for use in clinical settings, supporting their adoption for precise neurosurgical applications.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233144 | Class II | Active |
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Manufacturer
- Manufacturer
- Clearpoint Neuro, Inc.
Sources (2)
- FDA 510(k) K233144 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026