Arthrotek Cannula System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K934401 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arthrotek Cannula System is a surgical instrument set designed for meniscal repair procedures. It includes cannulas and probes used to guide and place meniscal fixation devices within the knee joint, facilitating precise placement during arthroscopic surgery.
This system is supplied as a reusable set and is intended for use in orthopedic surgical settings. The cannulas are available in straight and right-angle configurations, with specific catalog references (e.g., 905755, 905756) for identification. The device holds FDA 510(k) clearance under K934401, classified under the HRX product code and reviewed by the Orthopedic Advisory Committee in 1994.
Frequently asked questions
What types of knee surgeries is the Arthrotek Cannula System specifically designed for, and how does it assist during the procedure?
The Arthrotek Cannula System is designed for meniscal repair procedures within the knee joint. It includes cannulas and probes that guide and position meniscal fixation devices during arthroscopic surgery, ensuring precise placement of these devices inside the knee. This helps surgeons perform repairs with greater accuracy and control.
Is the Arthrotek Cannula System reusable, and if so, how should it be maintained between uses?
Yes, the Arthrotek Cannula System is supplied as a reusable set. Since it is intended for surgical use, proper cleaning, sterilization, and maintenance procedures must be followed between uses to ensure safety and functionality. Follow manufacturer guidelines for reprocessing to prevent contamination or damage.
What configurations of cannulas are available in the Arthrotek Cannula System, and how are they identified?
The system includes cannulas in two configurations: straight and right-angle designs. These are identified by specific catalog references, such as 905755 for one model and 905756 for another, allowing users to select the appropriate tool for their surgical approach.
How was the FDA clearance for the Arthrotek Cannula System determined, and what does this mean for its use in clinical settings?
The Arthrotek Cannula System received FDA clearance under 510(k) K934401 with a decision labeled *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously approved device, allowing it to be legally marketed and used in clinical settings for its intended purpose—meniscal repair procedures—following standard surgical protocols.
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: ARTHROTEK CANNULA SYSTEM (K934401) - FDA 510 (k), ARTHROTEK CANNULA SYSTEM (K934401) — FDA 510 (k) | Innolitics, ARTHROTEK CANNULA SYSTEM — K934401 · DeviceClearance, PDF K934401 - Arthrotek Cannula System, Arthrotek/Biomet Meniscus Screw Instrument Set - A-Z Ortho
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K934401 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K934401 24 fields · synced Sep 19, 2026