510(k) Report

Devices descending from K113848

7 later devices reach R3 Xlpe Liners 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
+1K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+1K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+1K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301