510(k) Report

Devices descending from K071887

28 later devices reach Sportmesh or Artelon Tissue Reinforcement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192112FlexBand PlusInternational Life Sciences20199—
+1K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+1K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+1K093799Tornier Surgical MeshTornier, Inc.20102—
+1K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+1K083307Synthasome X-RepairSynthasome, Inc.20099—
+2K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+2K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+2K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+2K203267The BioBrace ImplantBiorez, Inc.20214—
+2K141394X-RepairSynthasome20140—
+2K141499X-RepairslSynthasome, Inc.20140—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+2K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+3K260317Artelon Convenience KitsInternational Life Sciences20260—
+3K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+3K242187BioBrace®Conmed Corporation20241—
+3K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+3K211132ARISTE AB MeshAriste Medical, LLC20220—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+4K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+4K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—