510(k) Report

Devices descending from K082176

14 later devices reach LTM-BPS Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151083BioBridge Collagen MatrixFibralign Corporation20169—
+1K142326HP Tissue MatrixLifecell Corporation201411—
+1K112567Biomerix AssureBiomerix Corporation20110—
+1K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+2K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+2K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+3K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+3K260317Artelon Convenience KitsInternational Life Sciences20260—
+3K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+3K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+3K242187BioBrace®Conmed Corporation20241—
+4K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+4K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—