510(k) Report

Devices descending from K963486

15 later devices reach Revision Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+2K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+2K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+2K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+2K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+3K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+3K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—