Class Class II
WasherCap™ Mini Fixation System (Model 45) (K243712)
Description
WasherCap™ Mini Fixation System (Model 45) by Abanza Tecnomed S.L, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243712
Clearance Date2025-01-30
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243712
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. WasherCap™ Mini Fixation System (Model 45) (K243712) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221135 | X-Twist PEEK Suture Anchor | Parcus Medical, LLC | 2022 |
| K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 |
Trace the full predicate network for K243712
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.