# K254077: OSSIOfiber® Threaded Trimmable Fixation Nail

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: May 1, 2026 after 134 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 17 generations back to K962616 (1996). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241277: OSSIOfiber® Threaded Trimmable Fixation Nail, OSSIO, Ltd. (2024) Summary page 5.
- K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail, OSSIO, Ltd. (2023) Summary page 5.

## Indications for use
OSSIOfiber® Threaded Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot 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.

Source page: https://510kreport.com/device/K254077
Methodology: https://510kreport.com/methodology