510(k) Report

Devices descending from K913231

329 later devices reach S-Rom (TM) Total Lhip System W/Ceramic Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K192198Conformis Hip SystemConformis, Inc.2019121
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+6K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+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—
+6K152530UCP StemUnited Orthopedic Corporation20162—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+6K131952Corin Metafix Hip StemCorin USA20134—
+6K131884Avenir Cemented Hip StemZimmer GmbH20131—
+6K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+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—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+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—
+7K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+7K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K231925MINIMA S SystemLima Corporate S.P.A.20230—
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+7K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K211866Bencox THR SystemCorentec Co., Ltd.20210—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+7K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+7K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+7K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+7K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+7K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+7K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+7K163577Ecofit® Hip SystemImplantcast GmbH201791
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+7K121563Corin Trifit TS HipCorin USA2012101
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+8K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+8K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+8K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+8K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+8K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+8K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+8K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+8K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+8K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+8K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+8K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+8K201315PERFORM Humeral System – StemTornier, Inc.2020111
+8K192126AMIStem-P Short NeckMedacta International S.A.20191—
+8K181254Quadra PMedacta International S.A.20187—
+8K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+8K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+8K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+8K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—