510(k) Report

Devices descending from K062654

120 later devices reach Depuy Sigma Cruciate Retaining Porocoat Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+1K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191—
+1K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+1K140302Optetrak Logic Porous Femoral ComponentsExactech, Inc.20141—
+1K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+1K073602Modification to: Apex Knee SystemOmnlife Science200872—
+2K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.20260—
+2K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+2K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+2K181794Truliant Porous Femoral ComponentsExactech, Inc.20180—
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+2K102578Apex PS Knee SystemOmni Life Science, Inc.20118—
+2K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K201611Apex Knee SystemOmnilife Science20210—
+3K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+3K112891Apex Revision Knee SystemsOmni Life Science, Inc.201251
+3K111184Apex PS Knee System - PS-C InsertOmni Life Science, Inc.20112—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited20240—
+4K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K153437Apex Revision Knee SystemOmnilife Science201541
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+4K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K163332Apex Revision Knee SystemOmnilife Science20173—
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—