510(k) Report

Devices descending from K994078

50 later devices reach U1 Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+1K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+1K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+1K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+1K050262U2 Acetabular ComponentUnited Orthopedic Corp.200542—
+1K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+1K022520U2 Acetabular CupUnited Orthopedic Corp.200314—
+2K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+2K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+2K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+2K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA2013234
+2K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+2K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.201291
+2K103352Versafitcup CC TrioMedacta International20114—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+3K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K142761Corin TaperFit Hip StemCorin USA201541
+3K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—