OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
FDA 510(k) K201803 · OSSIO , Ltd.
510(k) numberK201803
Submission
- Device name
- OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
- Applicant
- OSSIO , Ltd.
Caesarea, IL - Received
- June 30, 2020
- Decision date
- October 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254077 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | 05/01/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | 02/24/2026SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | 05/27/2025SE |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI · Traditional | 04/03/2025SE |
| K241932 | OSSIOfiber® Compression StapleMNU · Traditional | 08/28/2024SE |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | 07/03/2024SE |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation NailsHWC · Traditional | 03/08/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | 12/01/2023SE |
| K233302 | OSSIOfiber® Compression StapleMNU · Traditional | 11/16/2023SE |
Questions and answers
When was OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant cleared by the FDA?
OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant (K201803) received a 510(k) decision of Substantially Equivalent on October 16, 2020, 108 days after the submission was received.
What is the product code of K201803?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.