# K193660: OSSIOfiber™ Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Jul 30, 2020 after 213 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: 12 generations back to K962616 (1996). 113 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 120 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.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 4.
- K060478: Arthrex Bio-Compression Screw, Arthrex, Inc. (2006) Summary page 4.

## Most influential descendants
- K221193: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (2022), 4 descendants of its own
- K213596: OSSIOfiber Compression Screw, 3.5mm (2021), 4 descendants of its own
- 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

## 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/K193660
Methodology: https://510kreport.com/methodology