Ez-6 Proximal Humeral Interamedullary Rod System
by Biodynamic Technologies, Inc.
510(k) K962552
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962552 | Date25 Sep 1996 | 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- Withdrawn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 EZ-6 Proximal Humeral Intramedullary Rod System is an intramedullary fixation device designed for stabilizing proximal humeral fractures. It consists of a cylindrical titanium alloy (Ti-6Al-4V) rod intended for internal skeletal fixation within the humerus. Available in diameters of 9mm, 11mm, 13mm, and 15mm, the rod is engineered to provide mechanical support to fractured bone segments, promoting proper alignment and healing. This device falls under the classification of orthopedic fixation rods, specifically intramedullary implants.
The system is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It is classified under FDA product code HSB and was granted a Traditional 510(k) clearance with a Substantially Equivalent determination by the Orthopedic (OR) Advisory Committee. Storage and handling must adhere to sterile medical device protocols, and the device is not intended for reuse. No MRI safety information is specified in the available data, and regulatory clearance was issued in 1996.
Other devices from Biodynamic Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the EZ-6 Proximal Humeral Intramedullary Rod System used for?
The EZ-6 Proximal Humeral Intramedullary Rod System is designed specifically for stabilizing and fixing proximal humeral fractures. It provides internal skeletal support to align fractured bone segments, facilitating proper healing and mechanical stability during recovery. This rod is inserted into the humerus to maintain alignment and reduce movement at the fracture site, which is critical for effective bone regeneration.
How is the EZ-6 Proximal Humeral Intramedullary Rod System supplied and is it reusable?
The EZ-6 Proximal Humeral Intramedullary Rod System is supplied as a sterile, single-use device. It is intended for one-time use in orthopedic surgical procedures to ensure patient safety and prevent cross-contamination. Reuse is not recommended or approved, as it could compromise sterility and device integrity.
What materials and sizes are available for the EZ-6 Proximal Humeral Intramedullary Rod System?
The rod is made from titanium alloy (Ti-6Al-4V), a material known for its strength and biocompatibility. It is available in four diameters: 9mm, 11mm, 13mm, and 15mm. The choice of diameter depends on the patient’s anatomy and the specific requirements of the fracture to ensure a secure fit and optimal stabilization.
How should the EZ-6 Proximal Humeral Intramedullary Rod System be stored?
The device must be stored according to sterile medical device protocols to maintain its integrity and sterility. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring it is not exposed to moisture or contamination. Proper storage is essential to preserve the device’s performance and safety for surgical use.
Is MRI safety information provided for the EZ-6 Proximal Humeral Intramedullary Rod System?
The available data for the EZ-6 Proximal Humeral Intramedullary Rod System does not specify MRI safety information. Clinicians should exercise caution and consult additional resources or manufacturer guidelines before subjecting patients with this device to MRI procedures, as titanium implants may pose risks in magnetic fields.