OSSIOfiber Compression Screw, 3.5mm
FDA 510(k) K213596 · OSSIO , Ltd.
510(k) numberK213596
Submission
- Device name
- OSSIOfiber Compression Screw, 3.5mm
- Applicant
- OSSIO , Ltd.
Caesarea, IL - Received
- November 12, 2021
- Decision date
- December 21, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 Compression Screw, 3.5mm cleared by the FDA?
OSSIOfiber Compression Screw, 3.5mm (K213596) received a 510(k) decision of Substantially Equivalent on December 21, 2021, 39 days after the submission was received.
What is the product code of K213596?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.