Class Class II
Acu-Sinch Knotless Mini (K243624)
Description
Acu-Sinch Knotless Mini by Acumed, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243624
Clearance Date2025-01-23
Clearance TypeTraditional
Product CodeHTN
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243624
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. Acu-Sinch Knotless Mini (K243624) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140328 | CMC MINI TIGHTROPE | Arthrex, Inc. | 2014 |
Trace the full predicate network for K243624
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.