510(k) Report

Devices descending from K111572

27 later devices reach Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+1K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+1K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+1K191831MobiliT CupCorin U.S.A. Limited20203—
+1K181744BI-MENTUM dual mobility systemSerf201810—
+1K171273LINK® BiMobile (TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG201842
+1K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+1K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+2K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+2K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC20240—
+2K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC20216—
+2K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—