Class Class II
Aevumed PHANTOM Suture Anchors (K242895)
Description
Aevumed PHANTOM Suture Anchors by Aevumed, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242895
Clearance Date2025-08-06
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242895
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. Aevumed PHANTOM Suture Anchors (K242895) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | 2023 |
| K180464 | AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. | 2018 |
Trace the full predicate network for K242895
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.