510(k) Report

Devices descending from K934060

37 later devices reach Howmedica (R) Acetabular Comp Pack/Manuf Meth Change through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp.199918—
+1K972792Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp.199716—
+1K955944Osteonics N2/Vac Packaging ProcessOsteonics Corp.19960—
+2K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K992153PE-Plus Acetabular CupPlus Orthopedics199915—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K241472Icona Hip StemCorin U.S.A. Limited20241—
+7K261576Icona Hip StemCorin, Ltd.20260—