510(k) Report

Devices descending from K973302

248 later devices reach Foundation Porous Hip Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072154Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P.2007611
+1K982367Reach Hip ComponentBiomet, Inc.1998209—
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+2K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+2K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+2K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+2K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp20080—
+2K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc.20032083
+3K243809Biolox® Delta Revision headsLimacorporate20250—
+3K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+3K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K182099Delta TT ProLima Corporate S.P.A.20183—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172651FMP Extended LinersEncore Medical L.P.20173—
+3K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+3K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+3K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+3K141327Minima S SystemLima Corporate S.P.A.20145—
+3K140830Exprt Revision KneeEncore Medical L.P.201471
+3K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+3K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+3K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.20061—
+3K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051381
+3K050251Balance Hip SystemBiomet, Inc.20052—
+3K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051—
+3K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+4K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+4K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+4K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+4K170473C2 femoral stemLima Corporate S.P.A.20170—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+4K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+4K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+4K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+4K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110—
+4K110245United Utf StemUnited Orthopedic Corporation201171
+4K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033—
+4K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+4K072101Rigi-Fix Hip Stem SystemImplants Intl., Ltd.20070—
+4K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200713719
+4K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+4K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+4K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250—
+5K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K243444Bioceram Azul® HeadKyocera Corporation20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+5K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.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—
+5K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+5K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—