Class Class II
OSSIOfiber® Interference Screw (K252022)
Description
OSSIOfiber® Interference Screw by OSSIO , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252022
Clearance Date2025-08-19
Clearance TypeTraditional
Product CodeMAI
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252022
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OSSIOfiber® Interference Screw (K252022) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2025 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | 2025 |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | 2024 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Scr... | OSSIO , Ltd. | 2023 |
| K202535 | Arthrex FastThread Interference Screw | Arthrex, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2026 |
Trace the full predicate network for K252022
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.