510(k) Report

Devices descending from K222501

3 later devices reach Regeneten Bioinductive Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242187BioBrace®Conmed Corporation20241—
+1K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+2K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—