RX-FIX Mini Rail External Fixator
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K150640
Overview
The RX-FIX Mini Rail External Fixator is a metallic external fixation system designed for stabilizing small bones. It is classified as an external fixator, specifically for use in orthopedic applications, and is intended for managing complex fractures such as comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. Its modular design allows for precise alignment and stabilization of bone fragments, facilitating proper healing and functional recovery. The device is engineered to provide a stable solution for bone lengthening and fracture management in delicate anatomical regions.
This external fixator is supplied as a reusable medical device, intended for use in clinical settings such as orthopedic surgery or trauma care. It is not sterile at the time of shipment but is designed to be sterilized prior to use, adhering to standard medical device sterilization protocols. The device is regulated under the FDA’s 510(k) clearance process (K150640) and falls under the Orthopedic advisory committee classification. Its modular components are tailored for small bones, ensuring compatibility with foot and hand procedures, and must be stored in accordance with manufacturer guidelines to maintain integrity and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150640 | Date1 Dec 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KTT
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What is the RX-FIX Mini Rail External Fixator used for?
The RX-FIX Mini Rail External Fixator is designed specifically for stabilizing small bones in orthopedic applications. It is intended for managing complex fractures such as comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. Its modular design allows for precise alignment and stabilization of bone fragments, aiding in proper healing and functional recovery in delicate anatomical regions.
Is the RX-FIX Mini Rail External Fixator reusable or single-use?
The RX-FIX Mini Rail External Fixator is supplied as a reusable medical device. It is not sterile at the time of shipment and must be sterilized prior to clinical use, following standard medical device sterilization protocols to ensure safety and functionality.
How should the RX-FIX Mini Rail External Fixator be stored?
The device must be stored in accordance with the manufacturer’s guidelines to maintain its integrity and functionality. Proper storage conditions help preserve the modular components and ensure they remain compatible for use in foot and hand procedures.
What regulatory pathway does the RX-FIX Mini Rail External Fixator follow?
The RX-FIX Mini Rail External Fixator is regulated under the FDA’s 510(k) clearance process, specifically under the Orthopedic advisory committee classification. It was granted clearance with the K-number K150640 and is classified as substantially equivalent to a predicate device.
Can this fixator be used for bone lengthening procedures?
Yes, the RX-FIX Mini Rail External Fixator is engineered to provide a stable solution for bone lengthening in addition to fracture management. Its modular design ensures compatibility with delicate anatomical regions, making it suitable for procedures requiring precise alignment and controlled bone elongation.