Class Class II
OSSIOfiber® Suture Anchor (K251309)
Description
OSSIOfiber® Suture Anchor by OSSIO , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251309
Clearance Date2025-05-27
Clearance TypeSpecial
Product CodeMAI
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251309
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® Suture Anchor (K251309) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213415 | OSSIOfiber Suture Anchor | OSSIO , Ltd. | 2022 |
| K192441 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2026 |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | 2025 |
Trace the full predicate network for K251309
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.