Brainlab Knee Arthroscopy
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K093118 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 Brainlab Knee Arthroscopy Navigation System is an orthopedic stereotaxic instrument designed for intraoperative image-guided navigation during knee arthroscopy procedures. It employs a freehand probe with a passive marker sensor system to map anatomical landmarks, enabling precise registration of patient-specific bone structures to a virtual computer model for surgical planning.
This system is used in operating room settings to assist surgeons in drilling transplant canals for procedures such as ACL reconstruction, enhancing joint stability. Supplied as a reusable medical device, it requires sterile preparation for each use and is classified under FDA regulation 882.4560 as a Class II orthopedic device. Authorized under FDA 510(k) clearance (K093118), it adheres to traditional review standards and is intended for use in MRI-unsafe environments.
Frequently asked questions
What specific knee procedures does the Brainlab Knee Arthroscopy Navigation System assist with during surgery?
The system is designed to assist surgeons in drilling transplant canals, particularly for procedures like ACL (anterior cruciate ligament) reconstruction, where precise alignment and placement are critical for restoring joint stability. Its image-guided navigation helps map anatomical landmarks to ensure accurate surgical planning and execution.
Is the Brainlab Knee Arthroscopy Navigation System reusable or single-use, and how should it be prepared for each procedure?
The device is reusable, but it must undergo sterile preparation before each use to ensure patient safety. Since it’s used in sterile operating room environments, proper cleaning, disinfection, and sterilization protocols must be followed as per medical device reprocessing guidelines.
Can this system be used in an MRI environment, and if not, why?
No, the Brainlab Knee Arthroscopy Navigation System is not MRI-safe. The device description explicitly states it is intended for use in MRI-unsafe environments, meaning it should not be used near MRI machines due to potential interference or safety risks.
What type of regulatory clearance does this device have, and how was it reviewed by the FDA?
The device holds FDA 510(k) clearance (K093118) under traditional review standards, meaning its safety and effectiveness were compared to a legally marketed predicate device. It was classified under FDA regulation 882.4560 as a Class II orthopedic device and reviewed by the Orthopedic Devices Panel (OR).
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: PDF BRAINLAB KNEE ARTHROSCOPY 510(k) K093118 - FDA.report, BRAINLAB KNEE ARTHROSCOPY (K093118) — FDA 510(k) | Innolitics, Knee3 Surgical Technique Overview | PDF | Knee | Anatomical ... - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093118 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K093118 24 fields · synced Sep 19, 2026