510(k) Report

Devices descending from K951671

154 later devices reach Osteonics Restoration Monolithic II Slotted Hip Stem Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+6K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+6K161226Revision Femoral StemLima Corporate S.P.A.20170—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH20168—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K261576Icona Hip StemCorin, Ltd.20260—
+7K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+7K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+7K203041SMS Cementless StemMedacta International S.A.20201—
+7K201673SMS Cementless StemMedacta International S.A.20203—
+7K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+7K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+7K170473C2 femoral stemLima Corporate S.P.A.20170—
+7K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+7K160011H-Max S stemLima Corporate S.P.A.20161—
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+8K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+9K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+9K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+9K163577Ecofit® Hip SystemImplantcast GmbH201791
+9K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+10K252451EPORE® XO cup systemImplantcast GmbH20260—
+10K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+10K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+10K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+10K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+10K210678implaFit® hip stemsImplantcast GmbH20223—
+10K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+10K203420EcoFit® Hip SystemImplantcast GmbH20214—
+10K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+10K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+10K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+11K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+11K252401implaFit® short stemsImplantcast GmbH20260—
+11K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+11K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+11K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+11K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+11K232371Actinia® hip stemsImplantcast GmbH20231—
+11K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—