Class Class II
Grappler Suture Anchor R3FLEX IOL System (K223589)
Description
Grappler Suture Anchor R3FLEX IOL System by Paragon 28, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223589
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223589
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. Grappler Suture Anchor R3FLEX IOL System (K223589) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | 2022 |
| K222194 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2022 |
| K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021 |
| K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024 |
Trace the full predicate network for K223589
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.