# K213596: OSSIOfiber Compression Screw, 3.5mm

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Dec 21, 2021 after 39 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: 13 generations back to K962616 (1996). 117 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193660: OSSIOfiber™ Compression Screws, OSSIO, Ltd. (2020) Summary page 4.
- K133842: Tyber Medical Trauma Screw, Tyber Medical, LLC (2014) 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® Compression Screws 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.

Source page: https://510kreport.com/device/K213596
Methodology: https://510kreport.com/methodology