510(k) Report

Devices descending from K933787

121 later devices reach Porocoat Porous Coating/Aml Proximally-Coated Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006120—
+2K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+2K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+2K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+2K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141—
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+2K073602Modification to: Apex Knee SystemOmnlife Science200872—
+3K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+3K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+3K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+3K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K102578Apex PS Knee SystemOmni Life Science, Inc.20118—
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+4K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+4K112891Apex Revision Knee SystemsOmni Life Science, Inc.201251
+4K111184Apex PS Knee System - PS-C InsertOmni Life Science, Inc.20112—
+5K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+5K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K153437Apex Revision Knee SystemOmnilife Science201541
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+5K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+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—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+6K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+6K163332Apex Revision Knee SystemOmnilife Science20173—
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+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—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K241043Augment Off-Axis Instrument SystemFix Surgical202415
+7K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+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—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+7K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+7K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+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—
+7K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—