510(k) Report

Devices descending from K962101

283 later devices reach Zweymueller SL Femoral Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K200391MPACT ExtensionMedacta International S.A.20210—
+7K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K202730Quadra-PMedacta International S.A.20201—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K193559NextAR TKA PlatformMedacta Inernational SA202012—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K192827Quadra-PMedacta International S.A.20206—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K143453Mpact Double Mobility SystemMedacta International20151—
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K131458Mpact DM Liner ConverterMedacta International20133—
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K122911Versafitcup CC Trio ExtensionMedacta International20121—
+7K122641Mpact ExtensionMedacta International201214—
+7K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+7K111145Endo HeadMedacta International20110—
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K211891DM Converter - TiN coatedMedacta International S.A.20220—
+8K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+8K220405Amis K LongMedacta International S.A.20220—
+8K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K202152NextAR TKA PlatformMedacta International S.A.202011—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+9K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+9K250477NextAR (TM) SpineMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+9K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+9K221104Actera™ hip systemConformis, Inc.202211
+10K252067Velora Acetabular SystemRestor3D, Inc.20250—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+10K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+10K231178ACTERA™ hip systemConformis, Inc.20230—
+11K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+11K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+11K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—