510(k) Report

Devices descending from K161221

6 later devices reach Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+1K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+2K202430Kerecis ReconstructKerecis Limited20213—
+3K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+3K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+3K243843Tendon Protect (50242)Kerecis Limited20250—