510(k) Report

Devices descending from K101296

11 later devices reach Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192798Zimmer Segmental SystemZimmer, Inc.20200—
+1K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc.20191—
+1K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc.201110—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K190100USTAR II SystemUnited Orthopedic Corporation201925
+2K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.20143—
+3K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+3K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516