510(k) Report

Devices descending from K021626

280 later devices reach Hallu Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+1K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+1K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+1K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+2K252061Distal Xtremities SystemTriMed, Inc.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+2K153395OS2-C Compression StapleIn2bones Sas20167—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K130510Arthrex Compression PlatesArthrex, Inc.20138—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K111266Easylock OsteosystemTriMed, Inc.20110—
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+2K052152B-Bop PlateNew Deal, S.A.20051—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+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—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K163440Stealth Staple SystemFirst Ray, LLC20173—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+3K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+3K103705Low Profile ScrewsArthrex, Inc.2011219—
+3K063831Basal Dorsal PlatesNewdeal Sas20070—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—