510(k) Report

Devices descending from K021728

184 later devices reach Ringloc Constrained Liners II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040601Exactech Acumatch a-Series & MCS Constrained Acetabular LinersExactech, Inc.200411
+1K030047Freedom Constrained LinersBiomet, Inc.2003181—
+2K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+2K071676Exactech Novation Crown Cup Constrained Liners and RingsExactech, Inc.200702
+2K061654Trident Constrained Acetabular InsertHowmedica Osteonics Corp.200620—
+2K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+3K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+3K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+3K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+3K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+3K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+3K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+3K110245United Utf StemUnited Orthopedic Corporation201171
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+3K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+3K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+3K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+3K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+4K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+4K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K172251UTS StemUnited Orthopedic Corporation20171—
+4K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+4K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+4K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+4K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+4K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+4K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—