# K231493: NITINEX Memory Compression Staple

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Aug 11, 2023 after 80 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: 4 generations back to K902307 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112837: Vilex EZ-Staple (Memory Bone Fixation Staple), Vilex, Inc. (2012) Summary page 4.

## Indications for use
The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Source page: https://510kreport.com/device/K231493
Methodology: https://510kreport.com/methodology