510(k) Report

Devices descending from K120211

18 later devices reach SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K170473C2 femoral stemLima Corporate S.P.A.20170—
+1K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc.20153—
+1K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.2013111
+1K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc.20128—
+1K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K203175POLARSTEM Cemented Femoral StemSmith & Nephew, Inc.20210—
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K160011H-Max S stemLima Corporate S.P.A.20161—
+2K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.201571
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.20241—
+3K211548POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc.20210—
+4K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc.20250—