Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
FDA 510(k)Class II (US FDA 510(k))
by Orthofix Srl
Identifiers
- 510(k) Number
- K173051 FDA 510(k)
- FDA Product Code
- HTY 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 MJ-FLEX is an intramedullary implant system designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation. It operates on the principle of balanced nailing to provide elasticity and stability at the fracture site. This device is specifically engineered for managing fractures in both upper and lower extremities, particularly in cases of narrow medullary canals or when preserving growth plates is important.
The MJ-FLEX THE NEW METAIZEAU NAIL is supplied as part of an intramedullary implant system for fracture management. It is intended for use in treating fractures following high-energy trauma. The device has received FDA 510(k) clearance with the product code HTY and is manufactured by Orthofix Srl in Bussolengo, Italy.
Frequently asked questions
What is the MJ-FLEX THE NEW METAIZEAU NAIL used for?
The MJ-FLEX is an intramedullary implant system designed for Elastic Stable Intramedullary Nailing (ESIN) fracture fixation. It operates on the principle of balanced nailing to provide elasticity and stability at the fracture site, specifically engineered for managing fractures in both upper and lower extremities.
How is the MJ-FLEX THE NEW METAIZEAU NAIL supplied?
The MJ-FLEX THE NEW METAIZEAU NAIL is supplied as part of an intramedullary implant system for fracture management. It is intended for use in treating fractures following high-energy trauma and is manufactured by Orthofix Srl in Bussolengo, Italy.
What is the regulatory status of the MJ-FLEX THE NEW METAIZEAU NAIL?
The MJ-FLEX THE NEW METAIZEAU NAIL has received FDA 510(k) clearance with the product code HTY. It was cleared on November 16, 2017, as substantially equivalent to predicate devices for orthopedic use.
Is the MJ-FLEX THE NEW METAIZEAU NAIL suitable for narrow medullary canals or pediatric cases?
Yes, the MJ-FLEX is specifically engineered for cases of narrow medullary canals and when preserving growth plates is important, making it suitable for both adult and pediatric fracture management in upper and lower extremities.
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 MJ-Flex - abscdn.orthofix.it, MJ-FLEX The new Metaizeau Nail Operative Technique -, 3A20 for Fractures - Orthofix, MJ-Flex™ - OrthoFixKids
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173051 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthofix Srl
Sources (1)
- FDA 510(k) K173051 24 fields · synced Sep 24, 2026