# K231458: Extremity Staple

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Aug 3, 2023 after 76 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902307 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc, Biomedical Enterprises, Inc. (2014) Summary page 5.

## Indications for use
The Extremity Staple System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The Extremity Staple System is intended for single use only.

Source page: https://510kreport.com/device/K231458
Methodology: https://510kreport.com/methodology