# K212594: OSSIOfiber® Staple

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Jan 21, 2022 after 158 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: 7 generations back to K915818 (1992). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153395: OS2-C Compression Staple, In2bones Sas (2016) Summary page 4.

## Most influential descendants
- K233302: OSSIOfiber® Compression Staple (2023), 1 descendant of its own
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own

## Indications for use
The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber® Staples must be adapted to the indication.

Source page: https://510kreport.com/device/K212594
Methodology: https://510kreport.com/methodology