510(k) Report

Devices descending from K972228

255 later devices reach Meridian Titanium Femoral Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+8K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+8K171156OMNI Anseris Hip StemOmnilife Science20170—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+8K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+9K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K251166Mfinity Femoral SystemMedacta International S.A.20250—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+9K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+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—
+9K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+10K252451EPORE® XO cup systemImplantcast GmbH20260—
+10K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+10K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+10K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+10K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+10K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+10K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+10K210678implaFit® hip stemsImplantcast GmbH20223—
+10K221104Actera™ hip systemConformis, Inc.202211
+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—
+11K252067Velora Acetabular SystemRestor3D, Inc.20250—
+11K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+11K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+11K232371Actinia® hip stemsImplantcast GmbH20231—
+11K231178ACTERA™ hip systemConformis, Inc.20230—
+11K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—