Class Class II
SuperBall-RC™ (K244015)
Description
SuperBall-RC™ by Arcuro Medical , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244015
Clearance Date2025-02-19
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244015
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. SuperBall-RC™ (K244015) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023 |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and... | T.A.G. Medical Products Corporation... | 2022 |
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | Rotation Medical, Inc. | 2013 |
Trace the full predicate network for K244015
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.