510(k) Report

Devices descending from K042811

22 later devices reach Vivosorb Sheet, Model FS01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+1K062558Mesosfol Surgical FilmBiomet Manufacturing Corp200721—
+2K112567Biomerix AssureBiomerix Corporation20110—
+2K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+3K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+4K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K193583Restrata®Acera Surgical, Inc.202011
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—