510(k) Report

Devices descending from K083566

10 later devices reach R3 Constrained Liner, Constrained Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K111635Smith & Nephew RJ Constrained LinersSmith & Nephew, Inc.20114—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+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
+2K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+2K122139Smith & Nephew R3 Constrained LinersSmith & Nephew, Inc.20121—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—