510(k) Report

Devices descending from K072154

61 later devices reach Foundation (FMP) Porous Coated Spiked Acetabular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+1K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K182099Delta TT ProLima Corporate S.P.A.20183—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172651FMP Extended LinersEncore Medical L.P.20173—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K140830Exprt Revision KneeEncore Medical L.P.201471
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K141006RSP Humeral Socket InsertDjo Global2014212
+3K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+4K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+5K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—