510(k) Report

Devices descending from K180191

2 later devices reach SuperBall Meniscal Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223500SuperBall Meniscal Repair SystemArcuro Medical, Ltd.20231—
+2K244015SuperBall-RC™Arcuro Medical, Ltd.20250—