Synthes Hindfoot Arthrodesis Nail System
by Synthes (Usa) 510(k)
Active
510(k) K051678
Overview
The Synthes Hindfoot Arthrodesis Nail System is a cannulated titanium orthopedic implant designed for arthrodesis (fusion) of hindfoot bones. It stabilizes the talus and calcaneus to correct deformities or treat conditions requiring rigid fixation, such as arthritis or traumatic injuries. The system includes cannulated nails, 6.0 mm locking screws, and end caps to secure the implant and prevent axial movement or rotation. Its cannulated design facilitates precise placement using guide wires, reducing surgical trauma.
This system is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under FDA product code HSB and was cleared via a Traditional 510(k) pathway by the Orthopedic Devices Advisory Committee. The titanium construction ensures MRI compatibility, and the components are sized for hindfoot applications. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and proper disposal follows standard orthopedic implant protocols.
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051678 | Date21 Sep 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Ongoing Z-1234-2024
Products not sterilized, sterility cannot be confirmed
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
Other devices from Synthes (Usa)
Questions
What is the Synthes Hindfoot Arthrodesis Nail System used for?
The Synthes Hindfoot Arthrodesis Nail System is designed specifically for arthrodesis (fusion) of the hindfoot bones, primarily the talus and calcaneus. It provides rigid fixation to correct deformities or treat conditions like arthritis, traumatic injuries, or other pathologies requiring stable bone alignment. The cannulated titanium nails and locking screws ensure secure placement while minimizing surgical trauma.
How is the Synthes Hindfoot Arthrodesis Nail System supplied and prepared for use?
The system is supplied sterile in its original packaging, ensuring readiness for immediate surgical use. It is intended for single-use only, adhering to standard orthopedic implant protocols. Before use, clinicians must verify the sterility seal and packaging integrity as per the manufacturer’s guidelines to maintain compliance and patient safety.
Is the implant reusable or single-use, and why?
The Synthes Hindfoot Arthrodesis Nail System is designed for single-use only. This is standard practice for orthopedic implants to prevent cross-contamination, ensure sterility, and maintain the integrity of the device’s structural and functional properties. Reuse could compromise patient safety and regulatory compliance.
What materials is the implant made from, and does it have any special compatibility features?
The system is constructed from titanium, a material known for its strength, biocompatibility, and durability. A key feature is its MRI compatibility, allowing for safe imaging post-surgery without interference. The cannulated design further enhances precision during placement using guide wires.
How should the Synthes Hindfoot Arthrodesis Nail System be stored, and what are the disposal guidelines?
Storage must follow the manufacturer’s instructions to preserve sterility and packaging integrity. Keep the system in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. For disposal, follow standard orthopedic implant protocols, including proper segregation and adherence to local regulations for medical device waste.