510(k) Report

Devices descending from K970337

83 later devices reach HA Global Taper (GT) Tapered Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+1K090982Smith & Nephew Hip Systems with HASmith & Nephew, Inc.201024—
+1K061066Synergy Hip SystemSmith & Nephew, Inc.200616—
+1K050849HA Coated Lag ScrewSmith & Nephew, Inc.200534—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+2K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+2K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+6K241539Activmotion SNewclip Technics20240—
+6K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+6K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K232371Actinia® hip stemsImplantcast GmbH20231—