510(k) Report

Devices descending from K121627

5 later devices reach Smith & Nephew Redapt Revision Femoral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+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