510(k) Report

Devices descending from K960094

18 later devices reach Reflection Dual Dimension Shell through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+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
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182099Delta TT ProLima Corporate S.P.A.20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—