# K233198: OSSIOfiber® Threaded Trimmable Fixation Nails

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Mar 8, 2024 after 162 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: 15 generations back to K962616 (1996). 127 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew), Inion OY (2013) Summary page 4.
- K193660: OSSIOfiber™ Compression Screws, OSSIO, Ltd. (2020) Summary page 4.
- K213596: OSSIOfiber Compression Screw, 3.5mm, OSSIO, Ltd. (2021) Summary page 4.
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm, OSSIO, Ltd. (2022) Summary page 4.
- K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail, OSSIO, Ltd. (2023). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- 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® 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/K233198
Methodology: https://510kreport.com/methodology