510(k) Report

Devices descending from K023743

35 later devices reach Smith & Nephew Global Bipolar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+1K061243Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc.2006191
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc.200618—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K111145Endo HeadMedacta International20110—
+3K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+4K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+4K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+4K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+4K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+5K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+6K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+6K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+6K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—