510(k) Report

Devices descending from K052830

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+1K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+1K083307Synthasome X-RepairSynthasome, Inc.20099—
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+1K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+2K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+2K211563Pitch-PatchsXiros, Ltd.20212—
+2K203267The BioBrace ImplantBiorez, Inc.20214—
+2K192112FlexBand PlusInternational Life Sciences20199—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K141394X-RepairSynthasome20140—
+2K141499X-RepairslSynthasome, Inc.20140—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+2K093799Tornier Surgical MeshTornier, Inc.20102—
+2K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+2K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+2K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+3K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+3K242187BioBrace®Conmed Corporation20241—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+3K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+3K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K211132ARISTE AB MeshAriste Medical, LLC20220—
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K260317Artelon Convenience KitsInternational Life Sciences20260—
+4K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+4K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K112567Biomerix AssureBiomerix Corporation20110—
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—