510(k) Report

Devices descending from K071016

13 later devices reach Depuy Restore Orthobiologic Soft Tissue Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+2K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+3K151083BioBridge Collagen MatrixFibralign Corporation20169—
+3K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+4K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+4K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K260317Artelon Convenience KitsInternational Life Sciences20260—
+5K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K242187BioBrace®Conmed Corporation20241—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—