510(k) Report

Devices descending from K021911

54 later devices reach Trident Crossfire Polyuethylene Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+1K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+1K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics2016171
+1K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+1K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+2K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+2K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+2K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics20225—
+2K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+2K210893Restoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20215—
+2K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.202061
+2K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20197—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics201882
+2K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+2K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+2K143453Mpact Double Mobility SystemMedacta International20151—
+2K131458Mpact DM Liner ConverterMedacta International20133—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103352Versafitcup CC TrioMedacta International20114—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+3K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K211891DM Converter - TiN coatedMedacta International S.A.20220—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K211866Bencox THR SystemCorentec Co., Ltd.20210—
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics20195—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K132879Mpact ExtensionMedacta International201411—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K111145Endo HeadMedacta International20110—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—