510(k) Report

Devices descending from K071065

44 later devices reach Orthadapt Bioimplant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+1K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+1K090288Orthadapt PRPegasus Biologics, Inc.20097—
+1K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+1K080353LTM-T Surgical MeshLifecell Corp.20084—
+1K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+2K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K192112FlexBand PlusInternational Life Sciences20199—
+2K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+2K093799Tornier Surgical MeshTornier, Inc.20102—
+2K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+2K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+2K083307Synthasome X-RepairSynthasome, Inc.20099—
+3K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+3K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+3K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+3K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+3K203267The BioBrace ImplantBiorez, Inc.20214—
+3K151083BioBridge Collagen MatrixFibralign Corporation20169—
+3K141394X-RepairSynthasome20140—
+3K141499X-RepairslSynthasome, Inc.20140—
+3K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K103787Medeor MatrixKensey Nash Corp.20112—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+4K260317Artelon Convenience KitsInternational Life Sciences20260—
+4K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+4K242187BioBrace®Conmed Corporation20241—
+4K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+4K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+5K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+5K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—