Small Joint System
by Smith & Nephew Dyonics, Inc. 510(k)
Active
510(k) K914559
Overview
The Small Joint System is a device used in orthopedic procedures. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.
The system was manufactured by Smith & Nephew Dyonics, Inc. and received FDA 510(k) clearance under K914559 with product code HRX. It is authorized for use in the United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914559 | Date18 Feb 1992 | 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- Withdrawn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
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Smith & Nephew Dyonics, Inc.
Questions
What clinical purpose does the Small Joint System serve?
The Small Joint System is intended for use in orthopedic procedures involving small joints. Its design supports the surgical repair or reconstruction of these joints, providing clinicians with a tool that has been evaluated for this specific application.
How was the Small Joint System cleared for market use?
The device received traditional 510(k) clearance (K914559) from the FDA, meaning it was found substantially equivalent to a legally marketed predicate device. This pathway demonstrates that the system meets the same safety and effectiveness standards as the reference device.
Which organization manufactures the Small Joint System and where is it located?
Smith & Nephew Dyonics, Inc. manufactures the Small Joint System. The company’s address is 160 Dascomb Rd., Andover, MA 01810, United States, as listed in the FDA submission.
What regulatory classification applies to the Small Joint System?
The device is classified under FDA product code HRX and was reviewed by the Orthopedic advisory committee (OR). Its clearance type is “Traditional” 510(k), indicating it followed the standard equivalence review process.