510(k) Report

Devices descending from K040166

324 later devices reach Depuy Sigma XLK Tibial Inserts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240—
+1K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.2011391
+1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114—
+1K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.2006611
+1K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005158—
+2K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+2K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+2K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+2K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.20240—
+2K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+2K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+2K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+2K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+2K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+2K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC20200—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+2K170806ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland)201721
+2K160700ATTUNE Revision Knee SystemDepuy (Ireland)201665
+2K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+2K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+2K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117—
+2K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc.20099—
+2K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc.200975—
+2K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation2008512
+2K070267Depuy GCK Tibial ComponentsDePuy Orthopaedics, Inc.200712—
+2K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc.200759—
+2K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+3K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+3K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K191814Alliance GlenoidZimmer, Inc.20194—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+3K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+3K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation2009505
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K193180Alliance Augmented GlenoidZimmer, Inc.20203—