510(k) Report

Devices descending from K981194

5 later devices reach Futura Biomedical Flexible Great Toe Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC20162—
+1K023086Classic Great Toe ImplantNexa Orthopedics, Inc.20021—
+2K191966NewPrim SystemBrm Extremities20200—
+2K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+2K023562Modification to Classic Great Toe ImplantNexa Orthopedics, Inc.20020—