Class Class II
SutureLoc™ Implant (K223284)
Description
SutureLoc™ Implant by Arthrex, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223284
Clearance Date2023-02-02
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223284
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. SutureLoc™ Implant (K223284) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203268 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2020 |
| K173845 | Arthrex SwiveLock | Arthrex, Inc. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230433 | Arthrex Knotless FiberTak Suture Anchor | Arthrex, Inc. | 2023 |
Trace the full predicate network for K223284
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.