510(k) Report

Devices descending from K000019

41 later devices reach Single Size Tendon Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243477Universal Tendon SpacerAskorn Medical20250—
+1K053655Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation200639—
+2K243843Tendon Protect (50242)Kerecis Limited20250—
+2K203496Nexo-Gide Bilayer Collagen MembraneGeistlich Pharma AG20210—
+2K162570Miromatrix Biological Mesh TWMiromatrix Medical, Inc.20171—
+2K160364VersaWrap Tendon ProtectorAlafair Biosciences, Inc.20166—
+2K080452Collagen Tendon WrapCollagen Matrix, Inc.200815—
+2K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+2K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2006131
+3K250109TYBR Collagen GelTybr Health20250—
+3K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+3K200311VersaWrap Tendon ProtectorAlafair Biosciences, Inc.20205—
+3K112423Collagen Tendon SheetRotation Medical, Inc.201114—
+3K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+4K223538Integrity ImplantAnika Therapeutics, Inc.20231—
+4K203600VersaWrapAlafair Biosciences, Inc.20214—
+4K201572TAPESTRY Biointegrative ImplantEmbody, Inc.20205—
+4K122048Collagen Tendon Sheet-DRotation Medical, Inc.20135—
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+5K250997Integrity™ ImplantAnika Therapeutics, Inc.20250—
+5K250021RotiumNanofiber Solutions, LLC20250—
+5K212306Tapestry Biointegrative ImplantEmbody, Inc.20212—
+5K213163VersaWrapAlafair Biosciences, Inc.20213—
+5K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc.20144—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+6K252647Tapestry Biointegrative ImplantEmbody, Inc.20250—
+6K240817VersaWrapAlafair Biosciences, Inc.20241—
+6K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.20233—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K220867Tapestry Biointegrative ImplantEmbody, Inc.20220—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K242187BioBrace®Conmed Corporation20241—
+7K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.20240—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—