# K230750: OSSIOfiber® Cannulated Trimmable Fixation Nail

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Sep 13, 2023 after 180 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K901456 (1990). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203465: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design, OSSIO, Ltd. (2021) Summary page 4.

## Most influential descendants
- K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (2023), 3 descendants of its own
- K233198: OSSIOfiber® Threaded Trimmable Fixation Nails (2024), 2 descendants of its own
- K241277: OSSIOfiber® Threaded Trimmable Fixation Nail (2024), 1 descendant of its own
- K254077: OSSIOfiber® Threaded Trimmable Fixation Nail (2026), 0 descendants of its own

## Indications for use
OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Source page: https://510kreport.com/device/K230750
Methodology: https://510kreport.com/methodology