Class Class II
OrthoButton AL (K230212)
Description
OrthoButton AL by Riverpoint Medical, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230212
Clearance Date2023-02-23
Clearance TypeSpecial
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230212
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. OrthoButton AL (K230212) cites 2 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171060 | OrthoButton AL | Riverpoint Medical | 2017 |
| K100652 | ACL TIGHTROPE | Arthrex, Inc. | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026 |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026 |
| K243988 | RootMend MRR | Riverpoint Medical, LLC | 2025 |
| K233552 | IDEAL Ziploop | Riverpoint Medical | 2023 |
Trace the full predicate network for K230212
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.