# K241932: OSSIOfiber® Compression Staple

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Aug 28, 2024 after 58 days
- Product code: MNU (Staple, Absorbable)
- 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: 9 generations back to K915818 (1992). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233302: OSSIOfiber® Compression Staple, OSSIO, Ltd. (2023) Summary page 5.
- K212594: OSSIOfiber® Staple, OSSIO, Ltd. (2022) Summary page 5.
- K210582: EasyClip® and EasyClip® Xpress, Stryker GmbH (2022) Summary page 5.

## Indications for use
The OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.

Source page: https://510kreport.com/device/K241932
Methodology: https://510kreport.com/methodology