510(k) Report

Devices descending from K920640

493 later devices reach Full Hemisphere Ring-Loc Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+9K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+9K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+9K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+9K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+9K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+9K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+9K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+9K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+9K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+9K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+9K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+9K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+9K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+9K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+9K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+9K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+9K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+9K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+9K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+9K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+9K130634Corin Metafix Hip StemCorin USA20135—
+9K121563Corin Trifit TS HipCorin USA2012101
+9K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+9K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+9K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+9K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+10K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+10K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+10K250644MSS - Monobloc stemMedacta International S.A.202611
+10K254003JARVIS Metaphyseal StemFH Industrie20260—
+10K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+10K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+10K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+10K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+10K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+10K243248Inhance Intact™Depuy Ireland UC20240—
+10K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+10K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+10K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+10K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+10K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+10K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+10K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+10K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+10K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+10K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+10K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+10K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+10K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+10K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+10K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+10K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+10K171249Entrada™ hip stemOrtho Development Corporation20172—
+10K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+10K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+10K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+10K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+10K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+10K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+10K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+10K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+11K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+11K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+11K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+11K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+11K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+11K251166Mfinity Femoral SystemMedacta International S.A.20250—
+11K251052Trivicta® Hip StemOrtho Development Corp.20250—
+11K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+11K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+11K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+11K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+11K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+11K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+11K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+11K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+11K211703Insignia Hip StemStryker Orthopaedics20217—
+11K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+11K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+11K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+11K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+11K171156OMNI Anseris Hip StemOmnilife Science20170—
+11K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+11K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+12K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+12K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+12K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+12K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+13K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+14K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+14K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+14K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—