# K162321: EasyClip Xpress

- Pathway: 510(k) (Traditional)
- Applicant: Restore Surgical, LLC Dba Instratek
- Decided: Feb 10, 2017 after 175 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). 7 ancestors in all.
2 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)
- K133523: Stapix Superelastic Implant Bone Staples, Instratek, Inc. (2014) Summary page 4.
- K122113: Memory Metal Staples, Easyclip, Stryker Corp. (2013) Summary page 4.

## Most influential descendants
- 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 EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

Source page: https://510kreport.com/device/K162321
Methodology: https://510kreport.com/methodology