Hexalon Biodegradable ACL/PCL Screw
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Inion Oy
Identifiers
- 510(k) Number
- K071464 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hexalon Biodegradable ACL/PCL Screw is a biodegradable interference screw classified as an orthopedic device. It is designed for the fixation of soft tissue tendon grafts, including applications in anterior cruciate ligament (ACL) reconstruction, such as single-bundle and double-bundle procedures. Constructed from degradable co-polymers of L-lactic acid, D-lactic acid, and trimethylene carbonate, the screw is engineered to gradually degrade in vivo through hydrolysis into metabolisable alpha-hydroxy acids.
This screw is supplied sterile and intended for single-use in arthroscopic surgical settings. Its green dye enhances visibility during insertion, aiding precise placement. Authorised under FDA 510(k) clearance and the Medical Devices Directive (MDD), it adheres to regulatory standards for orthopedic fixation devices. Storage and handling follow standard sterile surgical instrument protocols.
Frequently asked questions
What types of surgical procedures is the Hexalon Biodegradable ACL/PCL Screw specifically designed for?
The Hexalon Biodegradable ACL/PCL Screw is designed for fixation of soft tissue tendon grafts in arthroscopic ACL reconstruction procedures, including both single-bundle and double-bundle techniques. Its biodegradable composition and screw design are optimized for securing grafts in the tibial tunnel during these surgeries.
Is the screw reusable, or is it intended for single-use only?
The Hexalon Biodegradable ACL/PCL Screw is explicitly intended for single-use in arthroscopic settings. This aligns with standard sterile surgical protocols to ensure patient safety and prevent cross-contamination.
How does the green dye in the screw benefit the surgeon during surgery?
The green dye in the Hexalon Biodegradable ACL/PCL Screw enhances visibility during insertion, allowing surgeons to precisely locate and place the screw within the bone. This improves accuracy and confidence in graft fixation.
What materials is the screw made from, and how does it degrade in the body?
The screw is constructed from degradable co-polymers of L-lactic acid, D-lactic acid, and trimethylene carbonate. It degrades gradually in vivo through hydrolysis, breaking down into metabolizable alpha-hydroxy acids over time.
How should the screw be stored, and what are the handling requirements?
The Hexalon Biodegradable ACL/PCL Screw is supplied sterile and must be stored and handled according to standard sterile surgical instrument protocols. This ensures its integrity and sterility until use in the operating room.
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: Inion - Products - Hexalon™ Bioabsorbable Interference Screw, PDF Inion Hexalontm Biodegradable Acl/Pcl Screw Instructions for Use, INION HEXALON BIODEGRADABLE ACL/PCL SCREW by INION LTD. | FDA 510(k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K071464 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
Sources (2)
- FDA 510(k) K071464 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026