510(k) Report

Devices descending from K080452

15 later devices reach Collagen Tendon Wrap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112423Collagen Tendon SheetRotation Medical, Inc.201114—
+2K223538Integrity ImplantAnika Therapeutics, Inc.20231—
+2K201572TAPESTRY Biointegrative ImplantEmbody, Inc.20205—
+2K122048Collagen Tendon Sheet-DRotation Medical, Inc.20135—
+3K250997Integrity™ ImplantAnika Therapeutics, Inc.20250—
+3K250021RotiumNanofiber Solutions, LLC20250—
+3K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+3K212306Tapestry Biointegrative ImplantEmbody, Inc.20212—
+3K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc.20144—
+4K252647Tapestry Biointegrative ImplantEmbody, Inc.20250—
+4K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.20233—
+4K220867Tapestry Biointegrative ImplantEmbody, Inc.20220—
+5K242187BioBrace®Conmed Corporation20241—
+5K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—