# K210582: EasyClip® and EasyClip® Xpress

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jun 10, 2022 after 469 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: 6 generations back to K902307 (1990). 8 ancestors in all.
1 later device descends 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)
- K122113: Memory Metal Staples, Easyclip, Stryker Corp. (2013) Summary page 5.
- K162321: EasyClip Xpress, Restore Surgical, LLC Dba Instratek (2017) Summary page 5.

## Most influential descendants
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own

## Indications for use
The EasyClip® staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents). The EasyClip® Xpress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).

Source page: https://510kreport.com/device/K210582
Methodology: https://510kreport.com/methodology