510(k) Report

Devices descending from K061253

120 later devices reach Reflection 3 Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+4K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+5K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+5K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+7K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—