510(k) Report

Devices descending from K103755

48 later devices reach Taperloc Complete, Size 5 and 6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+1K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+1K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+1K163577Ecofit® Hip SystemImplantcast GmbH201791
+1K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+1K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+1K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+1K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+2K252451EPORE® XO cup systemImplantcast GmbH20260—
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+2K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+2K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+2K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+2K210678implaFit® hip stemsImplantcast GmbH20223—
+2K203420EcoFit® Hip SystemImplantcast GmbH20214—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+2K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+2K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+2K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+2K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+2K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+3K252401implaFit® short stemsImplantcast GmbH20260—
+3K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+3K232371Actinia® hip stemsImplantcast GmbH20231—
+3K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+3K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+3K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+3K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+3K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+3K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+3K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+3K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—