510(k) Report

Devices descending from K961378

384 later devices reach Delta Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+6K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+6K122305Corin Trinity-I Acetabular ShellCorin USA201228—
+6K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+6K121563Corin Trifit TS HipCorin USA2012101
+6K122099Bencox II Stem, Bencox Metal HeadCorentec Co., Ltd.20120—
+6K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128—
+6K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd.20128—
+6K121416GMK SphereMedacta International201220—
+6K120790GMK - Line ExtensionMedacta International201211—
+6K113571GMK Resufacing Patella Size 4Medacta International201223—
+6K111283GMK Revision Hybrid LinersMedacta International20110—
+6K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+6K090988GMK Total Knee SystemMedacta International S.A.2009521
+6K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+7K262057GMK ExtensionMedacta International SA20260—
+7K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+7K260831Z1 Hip SystemZimmer, Inc.20260—
+7K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+7K251906Z1 Hip SystemZimmer, Inc.20251—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+7K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+7K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K211664GMK Sphere RevisionMedacta International S.A.20210—
+7K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+7K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+7K210062Mectaplug PE IIMedacta International S.A.20210—
+7K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+7K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+7K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K192126AMIStem-P Short NeckMedacta International S.A.20191—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+7K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+7K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+7K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K181254Quadra PMedacta International S.A.20187—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+7K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+7K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K162035GMK SphereMedacta International S.A.201710—
+7K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+7K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+7K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+7K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K140826GMK Sphere ExtensionMedacta International201417—
+7K133630GMK Short StemMedacta International20131—
+7K131952Corin Metafix Hip StemCorin USA20134—
+7K123721GMK Revision ExtensionMedacta International20133—
+7K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+7K122232GMK NarrowMedacta International20128—
+7K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+7K111911Corin Optimom Modular HeadCorin USA201162—
+7K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+7K103721Mpact Acetabular SystemMedacta International201121—
+7K103352Versafitcup CC TrioMedacta International20114—
+7K102437GMK Revision Knee SystemMedacta International S.A.201034—
+7K093806Myknee Cutting BlocksMedacta International S.A.201016—
+8K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+8K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+8K241461Mpact Constrained LinerMedacta International S.A.20251—
+8K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—