# K181180: OSSIO™ Pin Product Family

- Pathway: 510(k) (Traditional)
- Applicant: OSSIO, Ltd.
- Decided: Jan 10, 2019 after 253 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: 3 generations back to K901456 (1990). 5 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050275: Modification to: Inion Otps Biodegradable Pin, Inion, Ltd. (2005) Summary page 4.

## Most influential descendants
- K203465: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design (2021), 5 descendants of its own
- K230750: OSSIOfiber® Cannulated Trimmable Fixation Nail (2023), 4 descendants of its own
- K250646: Impact PEEK Union Nail System (2025), 3 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

## Indications for use
The OSSIO™ Pin Product Family is 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/K181180
Methodology: https://510kreport.com/methodology