# OSSIO, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 20 (2019–2026): 20 510(k) clearances
- Product codes: HWC (6), HTY (6), MAI (5), MNU (3)
- 510(k) review time since 2016: median 134 days, against 93 for FDA's reviews in the same codes and years (5 of 17 faster)
- Predicates its devices cite: 42 (27 its own); citations of its devices by later devices: 29 (27 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)
- Inion, Ltd.: 3 (https://510kreport.com/company/inion)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- In2bones Sas: 2 (https://510kreport.com/company/in2bones)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Depuy Mitek: 1 (https://510kreport.com/company/depuy-mitek)
- Tyber Medical, LLC: 1 (https://510kreport.com/company/tyber-medical)

## Firms that cite its devices most
- Restor3D: 1 (https://510kreport.com/company/restor3d)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)

## Its most-cited devices
- K181180: OSSIO™ Pin Product Family (2019), cited by 5
- K193660: OSSIOfiber™ Compression Screws (2020), cited by 4
- K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (2023), cited by 3
- K203465: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design (2021), cited by 3
- K213415: OSSIOfiber Suture Anchor (2022), cited by 2
- K213596: OSSIOfiber Compression Screw, 3.5mm (2021), cited by 2

## Recent decisions
- K254077: OSSIOfiber® Threaded Trimmable Fixation Nail (May 1, 2026)
- K254055: OSSIOfiber® Suture Anchor (Feb 24, 2026)
- K252022: OSSIOfiber® Interference Screw (Aug 19, 2025)
- K251309: OSSIOfiber® Suture Anchor (May 27, 2025)
- K243760: OSSIOfiber® Suture Anchor 2.5-3.5 mm (Apr 3, 2025)
- K241932: OSSIOfiber® Compression Staple (Aug 28, 2024)
- K241277: OSSIOfiber® Threaded Trimmable Fixation Nail (Jul 3, 2024)
- K233198: OSSIOfiber® Threaded Trimmable Fixation Nails (Mar 8, 2024)

Source page: https://510kreport.com/company/ossio