TRIGEN INTERTAN 10S Nail System
510(k) K241804
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241804 | Date22 Aug 2024 | 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- Withdrawn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
- JDS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Trigen Intertan 10S Nail System is a bone fixation device classified as an intramedullary nail for orthopedic use. It is designed to stabilize intertrochanteric fractures of the femur, providing mechanical support to promote proper healing and alignment through antegrade insertion.
This device is supplied as a sterile, single-use system and is intended for use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K241804) as a Class II device (product code JDS) and adheres to regulatory standards for orthopedic implants. The system includes components for antegrade insertion and fixation, with specific sizing tailored for femoral anatomy.
Other devices from Smith & Nephew, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Trigen Intertan 10S Nail System used for?
The Trigen Intertan 10S Nail System is designed specifically to stabilize intertrochanteric fractures of the femur. By providing mechanical support through antegrade insertion, it promotes proper alignment and facilitates healing of these complex hip fractures. This is particularly important for maintaining bone integrity and functional recovery in orthopedic surgery.
How is the Trigen Intertan 10S Nail System supplied?
This device is supplied as a sterile, single-use system. Sterility ensures patient safety by preventing infection during surgery, while the single-use nature eliminates the need for reprocessing, reducing contamination risks. Each system is packaged and prepared for immediate clinical use in orthopedic surgical settings.
Is the Trigen Intertan 10S Nail System reusable?
No, the Trigen Intertan 10S Nail System is intended for single-use only. Single-use medical devices are designed to be used once and then discarded. This approach minimizes the risk of cross-contamination and ensures consistent performance, which is critical for orthopedic implants where reliability is paramount.
What sizes are available for the Trigen Intertan 10S Nail System?
The system includes components tailored for femoral anatomy, though the exact sizing details are not specified in the provided data. Typically, intramedullary nails like this come in a range of diameters and lengths to accommodate different patient anatomies and fracture patterns. For precise sizing, refer to the manufacturer’s product documentation or consult with a surgical specialist.
How should the Trigen Intertan 10S Nail System be stored?
As a sterile, single-use device, the Trigen Intertan 10S Nail System should be stored in its original, unopened packaging to maintain sterility. It should be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s storage guidelines to ensure the device remains viable until use.