510(k) Report

Devices descending from K974807

151 later devices reach Osteo Austin Moore Endoprosthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131884Avenir Cemented Hip StemZimmer GmbH20131—
+6K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+6K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+6K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+7K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+7K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K233476Z1 Hip SystemOrchard Medical Development202421
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K223441SpaceFlex Acetabular CupG21, S.R.L.20230—
+7K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+7K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+7K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+7K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+7K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+7K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+7K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+7K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+7K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+8K260831Z1 Hip SystemZimmer, Inc.20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K251906Z1 Hip SystemZimmer, Inc.20251—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K192126AMIStem-P Short NeckMedacta International S.A.20191—
+8K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+8K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+8K181254Quadra PMedacta International S.A.20187—
+8K170473C2 femoral stemLima Corporate S.P.A.20170—
+8K160011H-Max S stemLima Corporate S.P.A.20161—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+9K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+9K202730Quadra-PMedacta International S.A.20201—
+9K192827Quadra-PMedacta International S.A.20206—
+10K220405Amis K LongMedacta International S.A.20220—
+10K210062Mectaplug PE IIMedacta International S.A.20210—