510(k) Report

Devices descending from K192112

9 later devices reach FlexBand Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+1K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+1K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+2K260317Artelon Convenience KitsInternational Life Sciences20260—
+2K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+2K242187BioBrace®Conmed Corporation20241—
+3K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+3K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—