# K112837: Vilex EZ-Staple (Memory Bone Fixation Staple)

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, Inc.
- Decided: Oct 9, 2012 after 377 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: 3 generations back to K902307 (1990). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 1.

## Most influential descendants
- K161426: NeoSpan Compression Staple Impant w/instruments (2016), 2 descendants of its own
- K233089: NeoSpan® Compression Implant System (2024), 0 descendants of its own
- K231493: NITINEX Memory Compression Staple (2023), 0 descendants of its own
- K190385: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (2019), 0 descendants of its own
- K150211: EzFuze Implant System (2015), 0 descendants of its own

## Indications for use
The Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Source page: https://510kreport.com/device/K112837
Methodology: https://510kreport.com/methodology