510(k) Report

Devices descending from K961497

628 later devices reach Profyle Titanium Hand and Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+3K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+3K201656ARIX Elbow SystemJeil Medical Corporation20200—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+3K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+3K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.20176—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K161746ARIX Hand SystemJeil Medical Corporation20161—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.20160—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20160—
+3K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+3K151468ARIX Wrist SystemJeil Medical Corporation20167—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K130830Integra Laminoplasty SystemSeaspine, Inc.20132—
+3K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121—
+3K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+3K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+3K103705Low Profile ScrewsArthrex, Inc.2011219—
+3K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+3K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+3K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+3K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+3K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+3K063831Basal Dorsal PlatesNewdeal Sas20070—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—