# K133523: Stapix Superelastic Implant Bone Staples

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Feb 6, 2014 after 83 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). 6 ancestors in all.
3 later devices descend from it; 1 cites 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.
- K122113: Memory Metal Staples, Easyclip, Stryker Corp. (2013) Summary page 1.
- K051408: Intelifuse, Inc. Warm System with Stimulinks, Intelifuse, Inc. (2005) Summary page 1.

## Most influential descendants
- K162321: EasyClip Xpress (2017), 2 descendants of its own
- K210582: EasyClip® and EasyClip® Xpress (2022), 1 descendant of its own
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own

## Indications for use
The Instratek STAPIXTM Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.

Source page: https://510kreport.com/device/K133523
Methodology: https://510kreport.com/methodology