Valor Hindfoot Fusion Nail System
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K142602
Overview
The Valor Hindfoot Fusion Nail System is an orthopedic device designed for hindfoot arthrodesis. It is an intramedullary nail system intended to provide stabilization and fusion of the hindfoot joints.
The system is supplied as a reusable implant system and includes instrumentation for surgical implantation. It received FDA 510(k) clearance (K142602) and is substantially equivalent to a predicate device. The device is not MRI safe unless otherwise specified, and sterility and single-use status are not indicated in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142602 | Date22 Oct 2014 | 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- Withdrawn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
- HSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What is the VALOR Hindfoot Fusion Nail System used for?
The VALOR Hindfoot Fusion Nail System is designed for hindfoot arthrodesis, providing stabilization and fusion of the hindfoot joints as an intramedullary nail system in orthopedic surgery.
Is the VALOR Hindfoot Fusion Nail System reusable or single-use?
The system is supplied as a reusable implant system, meaning the implants and instrumentation are intended for multiple uses after appropriate reprocessing, based on the provided device data.
What regulatory pathway was used for the VALOR Hindfoot Fusion Nail System?
The device received FDA 510(k) clearance under K142602, indicating it was found substantially equivalent to a predicate device through the 510(k) premarket notification process.
What components are included with the VALOR Hindfoot Fusion Nail System?
The system includes the intramedullary nail implants and associated instrumentation for surgical implantation, supplied as a reusable implant system for hindfoot fusion procedures.
Is the VALOR Hindfoot Fusion Nail System MRI safe?
The device is not MRI safe unless otherwise specified, as stated in the provided data, so MRI compatibility should be confirmed on a case-by-case basis.