510(k) Report

Devices descending from K864671

9 later devices reach Anatomic Modular Knee (Amk) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+1K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc.19993—
+1K982585Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision SystemDePuy Orthopaedics, Inc.19980—
+2K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+2K190100USTAR II SystemUnited Orthopedic Corporation201925
+2K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc.20010—
+3K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+3K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—