510(k) Report

Devices descending from K934412

377 later devices reach Coated ZT Proximal Sleeve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K130634Corin Metafix Hip StemCorin USA20135—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+5K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.20126—
+5K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+5K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+5K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+5K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+5K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+5K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+5K082525Corin Metafix Femoral StemCorin USA2010712
+5K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+5K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+6K243466Conformity Stem Extension Line, #0United Orthopedic Corporation20250—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K242249Conformity Stem Extension LineUnited Orthopedic Corporation20241—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+6K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K220405Amis K LongMedacta International S.A.20220—
+6K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+6K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K192198Conformis Hip SystemConformis, Inc.2019121
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+6K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.201661
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+6K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+6K152530UCP StemUnited Orthopedic Corporation20162—
+6K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+6K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+6K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+6K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K103518Trinity Acetabular SystemCorin USA20118—
+7K260831Z1 Hip SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+7K250644MSS - Monobloc stemMedacta International S.A.202611
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K251906Z1 Hip SystemZimmer, Inc.20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+7K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415