510(k) Report

Devices descending from K113789

8 later devices reach Modular Proximally Fluted Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+2K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+2K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301