CUVIS-Joint (CJ150)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by CUREXO, Inc.
Identifiers
- 510(k) Number
- K252037 FDA 510(k)
- FDA Product Code
- OLO 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 CUVIS-Joint (CJ150) is a diagnostic imaging device classified as a Joint Arthroscopy Imaging System under the FDA’s product code OLO. It is designed to provide real-time visualization of joint structures, aiding in the assessment of internal joint conditions during arthroscopic procedures. The system integrates imaging technology to enhance surgical precision and diagnostic accuracy for musculoskeletal evaluations.
This device is supplied as a reusable medical instrument, intended for use in sterile operating environments such as orthopedic surgery suites. It is regulated under the FDA’s 510(k) pathway, with a clearance decision dated March 25, 2026, following review by the Orthopaedic Devices Panel (OR). Compliance with MRI safety standards and proper sterilization protocols are critical for its clinical application, as specified in the manufacturer’s instructions.
Frequently asked questions
What types of joint procedures is the CUVIS-Joint (CJ150) designed to assist with during surgery?
The CUVIS-Joint (CJ150) is specifically designed to provide real-time visualization of joint structures during arthroscopic procedures. This imaging system aids in assessing internal joint conditions, helping surgeons evaluate musculoskeletal issues with greater precision. It is particularly useful for procedures where clear visualization of the joint anatomy is critical, such as diagnostic arthroscopy or minor corrective surgeries.
Is the CUVIS-Joint (CJ150) intended for single-use or can it be reused in multiple procedures?
The CUVIS-Joint (CJ150) is supplied as a reusable medical instrument, meaning it is engineered for repeated use in sterile operating environments. However, proper sterilization protocols must be followed between procedures to ensure safety and compliance with manufacturer guidelines. Reusability is contingent on adherence to MRI safety standards and sterilization procedures outlined in the device’s instructions.
How is the CUVIS-Joint (CJ150) regulated, and what does its clearance status entail?
The CUVIS-Joint (CJ150) is regulated under the FDA’s 510(k) pathway, with a clearance decision dated March 25, 2026. It was determined to be substantially equivalent to a legally marketed predicate device, as reviewed by the Orthopaedic Devices Panel (OR). This clearance indicates that the device meets FDA requirements for safety and effectiveness as a Joint Arthroscopy Imaging System under product code OLO, though it does not imply any specific clinical indication beyond its described use.
What environmental and handling conditions should be considered when storing the CUVIS-Joint (CJ150) before use?
Since the CUVIS-Joint (CJ150) is a reusable device intended for sterile operating environments, it must be stored in a clean, dry location away from direct sunlight or extreme temperatures. Before use, it requires proper sterilization to maintain safety and functionality. Additionally, compliance with MRI safety standards is critical, as the device may be used in MRI-compatible settings, so storage should account for electromagnetic interference risks if applicable.
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 | K252037 | Class II | Active |
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Manufacturer
- Manufacturer
- CUREXO, Inc.
Sources (2)
- FDA 510(k) K252037 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 14, 2026