510(k) Report

Devices descending from K130728

11 later devices reach Polarstem Standard and Lateral Femoral Stems with TI/HA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K203175POLARSTEM Cemented Femoral StemSmith & Nephew, Inc.20210—
+1K160011H-Max S stemLima Corporate S.P.A.20161—
+1K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.201571
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.20241—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K211548POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc.20210—
+2K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc.20250—