510(k) Report

Devices descending from K954935

326 later devices reach S-Rom Femoral Hip Stem - Size 14 X 8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110—
+5K103518Trinity Acetabular SystemCorin USA20118—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K211866Bencox THR SystemCorentec Co., Ltd.20210—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+6K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+6K191056Conformity stem, cementedUnited Orthopedic Corporation20200—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K172806Bencox Mirabo Cup SystemCorentec Co., Ltd.20174—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K121563Corin Trifit TS HipCorin USA2012101
+7K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+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—
+7K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415
+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—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+7K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+7K192126AMIStem-P Short NeckMedacta International S.A.20191—
+7K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+7K181254Quadra PMedacta International S.A.20187—
+7K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+7K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+7K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+7K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+7K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+7K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+8K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202602
+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—
+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—
+8K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—