510(k) Report

Devices descending from K880282

135 later devices reach Lima-Lto. Sem Modular External Stablizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082679Laki Hand Fixation System, Model TFX.3X.06.XSintea Biotech, Inc.20090—
+1K964094MinifixFerguson Medical1996133—
+2K093550Mini Rail External Fixator SystemSmall Bone Innovations, Inc.20108—
+2K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006120—
+2K051017R-X-Fix External FixatorR-X-Fix20051—
+2K023314MicrofixFixano SA20020—
+3K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+3K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.20200—
+3K172438ARBOR External Fixation SystemGlobus Medical, Inc.20180—
+3K150640RX-FIX Mini Rail External FixatorWrightmedicaltechnologyinc20150—
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K140158S.E.a.L. Fracture Fusion TubeDne, LLC20140—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K113848R3 Xlpe LinersSmith & Nephew, Inc.201272
+3K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.201035—
+3K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+3K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016—
+3K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc.20101—
+3K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc.200946—
+3K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.2007916
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K213842ONVOY Acetabular SystemGlobus Medical, Inc.20221—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K211330R3 Large Head LinersSmith & Nephew, Inc.20220—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K182535R3 Anteverted LinersSmith & Nephew, Inc.20184—
+4K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.20170—
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.20166—
+4K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K130652Vitalite E Cross-Linked Polyethylene Acetabular InsertConsensus Orthopedics, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+4K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+4K110101Taper Oxinium Femoral HeadSmith & Nephew, Inc.20115—
+4K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K103352Versafitcup CC TrioMedacta International20114—
+4K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc.20116—
+4K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+4K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+5K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+5K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.20175—
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+5K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+5K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.20164—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+5K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+5K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+5K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+5K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+5K132879Mpact ExtensionMedacta International201411—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+5K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—