510(k) Report

Devices descending from K093363

16 later devices reach Cocr and Oxinium Femoral Heads and R3 Xlpe Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+1K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+1K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+1K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+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
+2K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+2K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+3K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—