510(k) Report

Devices descending from K060358

69 later devices reach Profemur TL Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K123688Profemur TL Classic Hip StemWrightmedicaltechnologyinc20135—
+1K112080Preserve Hip StemWrightmedicaltechnologyinc20118—
+1K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+1K110399Gladiator Plasma Classic Hip StemWrightmedicaltechnologyinc20112—
+1K102565Anterior Approach Hip Surgery InstrumentsWrightmedicaltechnologyinc20100—
+1K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+1K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+2K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+2K191632PROFEMUR TL2 StemsMicroport Orthopedics, Inc.20192—
+2K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—
+2K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc.20153—
+2K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc.20154—
+2K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc20120—
+2K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc20123—
+2K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH201101
+2K083312Minihip StemCorin USA201015—
+2K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+2K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+2K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+2K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+3K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+3K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+3K162775Legion Cone SystemSmith & Nephew, Inc.201752
+3K131986Corin Minihip StemCorin USA20133—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+3K103518Trinity Acetabular SystemCorin USA20118—
+3K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+3K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+4K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+4K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+4K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—