510(k) Report

Devices descending from K896580

22 later devices reach Uni-Polar Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K111145Endo HeadMedacta International20110—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+1K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc.200618—
+1K061243Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc.2006191
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+2K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+2K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+2K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+2K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+3K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+3K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+4K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—