Double Engine Intrameddullary Nail System
by Xiamen Double Engine Medical Material Co., Ltd.
510(k) K131609
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131609 | Date21 May 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Double Engine Intramedullary Nail System is an orthopedic fixation device classified as an intramedullary nail (Device Type: HSB). It is designed for internal fixation of tibial fractures, providing axial alignment, stabilization, and rotational control within the medullary canal. Constructed from titanium alloy, the system includes interlocking screws and end caps to secure the nail in place and facilitate adjustment or removal. Its primary function is to restore mechanical integrity to fractured tibias, whether due to trauma or pathological conditions.
This system is intended for use in clinical orthopedic settings by surgeons, requiring sterile handling and single-use application. The titanium alloy components ensure biocompatibility and MRI safety, though MRI compatibility should be confirmed with the manufacturer. Supplied as a sterile, ready-to-use kit, the system includes nails, screws, and end caps in standardized sizes for tibial fixation. Authorized for commercial distribution in the U.S. under FDA 510(k) clearance (K131609), it adheres to regulatory standards for orthopedic implants.
Other devices from Xiamen Double Engine Medical Material Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Double Engine Intramedullary Nail System used for?
The Double Engine Intramedullary Nail System is designed specifically for internal fixation of tibial fractures, whether caused by trauma or pathological conditions. It provides axial alignment, stabilization, and rotational control within the medullary canal to restore mechanical integrity to the fractured tibia. This ensures proper healing by maintaining the bone’s structural alignment during recovery.
How is the system supplied, and is it sterile?
The Double Engine Intramedullary Nail System is supplied as a sterile, ready-to-use kit. This ensures that all components—including the titanium alloy nails, interlocking screws, and end caps—are pre-sterilized and packaged for immediate clinical use, reducing the risk of infection and simplifying surgical preparation.
Is this device intended for single-use or reuse?
The system is intended for single-use only. Single-use devices minimize the risk of cross-contamination and ensure patient safety by preventing the reuse of components that may degrade or become compromised during a procedure. Always follow manufacturer guidelines for proper disposal after use.
What materials are used in the Double Engine Intramedullary Nail System?
The system is constructed from titanium alloy, which provides excellent biocompatibility and corrosion resistance. This material choice also ensures MRI safety, though users should confirm MRI compatibility with the manufacturer before imaging. Titanium alloy is commonly used in orthopedic implants for its strength and compatibility with the human body.
How are the sizes of the nails, screws, and end caps standardized?
The Double Engine Intramedullary Nail System includes nails, screws, and end caps in standardized sizes tailored for tibial fixation. These sizes are designed to accommodate various fracture patterns and anatomical requirements, ensuring a secure and stable fit. The kit is pre-assorted to simplify surgical planning and reduce the need for additional customization during the procedure.