510(k) Report

Devices descending from K122048

5 later devices reach Collagen Tendon Sheet-D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc.20144—
+2K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.20233—
+3K242187BioBrace®Conmed Corporation20241—
+3K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+4K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—