Bone Staple(s)
by Synthes (Usa) 510(k)
Active
510(k) K904553
Overview
Bone staple(s) is a fixation device used in orthopedic procedures to secure bone fragments or grafts. It is classified under product code JDR as a staple, fixation, bone device.
The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is indicated for use in orthopedic settings and has received FDA 510(k) clearance (K904553) as substantially equivalent to a predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904553 | Date21 Dec 1990 | 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- Withdrawn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
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synthes (Usa)
Questions
What is the bone staple(s) used for?
The bone staple(s) is a fixation device used in orthopedic procedures to secure bone fragments or grafts, as stated in the device description. It is indicated for use in orthopedic settings to stabilize bone during healing or fusion processes.
How is the bone staple(s) supplied and is it sterile?
The device is supplied non-sterile, meaning it does not arrive in a sterile condition from the manufacturer. It must be cleaned and sterilized by the user before each use, as specified in the device data under the description section.
Can the bone staple(s) be reused?
Yes, the bone staple(s) is intended for reusable use after appropriate cleaning and sterilization by the user, as explicitly stated in the device description. This means it can be used multiple times following proper reprocessing between uses.
What regulatory pathway was used for the bone staple(s)?
The device received FDA 510(k) clearance under the traditional pathway, as indicated by the authorization field 'FDA_510K' and the clearance_type 'Traditional' in the specifications. It was found substantially equivalent to a predicate device, with decision_code SESE and K-number K904553.
What product code classifies the bone staple(s)?
The bone staple(s) is classified under product code JDR, which corresponds to a staple, fixation, bone device, as noted in both the description and specifications sections of the device data.