510(k) Report

Devices descending from K932755

246 later devices reach Reflection Acetabular Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+4K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.20175—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.20164—
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.20165—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+4K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+4K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+4K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+4K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+4K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+4K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+4K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.201236—
+4K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+4K122641Mpact ExtensionMedacta International201214—
+4K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+4K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+4K113320Novation Element Femoral Stem, 12/14 Collarless Standard/High Offset HA Coated…Exactech, Inc.20120—
+4K111145Endo HeadMedacta International20110—
+4K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054—
+4K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—
+4K063279Novation Splined RDD Femoral StemsExactech, Inc.200602
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+5K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+5K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+5K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230—
+5K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+5K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190847REDAPT Blade AugmentsSmith & Nephew, Inc.20190—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K182099Delta TT ProLima Corporate S.P.A.20183—
+5K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184—
+5K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+5K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+5K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+5K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—