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
+1K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+1K111266Easylock OsteosystemTriMed, Inc.20110—
+1K071797Mondeal Hand Contour SystemMondeal Medical Systems GmbH20070—
+1K062498Profyle SystemHowmedica Osteonics Corp.2006811
+1K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+1K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+1K032534Synthes AfsSynthes Spine200443—
+1K021626Hallu PlatesNew Deal, S.A.2002280—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K253906Xpert HandNewclip Technics20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+2K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K213214Xpert WristNewclip Technics20210—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K191927Hinged Laminoplasty SystemLife Spine, Inc.20190—
+2K181717Life Spine Laminoplasty SystemLife Spine, Inc.20181—
+2K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+2K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+2K180500VariAx 2 SystemStryker GmbH201812—
+2K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+2K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184—
+2K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K141489Linos Moh Hand Plating SystemKLS Martin L.P.20143—
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K132740Spinefrontier Lesplasty Posterior Cervical Laminoplasty SystemSpinefrontier, Inc.20130—
+2K131566Arix Hand SystemJeil Medical Corporation20138—
+2K130510Arthrex Compression PlatesArthrex, Inc.20138—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K122822Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC20135—
+2K121276Neuro Vention Laminplasty Plating SystemNeurovention, LLC20120—
+2K111048Synthes Scout Tack FixationSynthes Spine20120—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K113802Escalate Laminoplasty SystemStryker Spine20127—
+2K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+2K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+2K103332Aptus Ulna PlatesMedartis AG201171—
+2K102537Aptus 1.5 TrilockMedartis AG201019—
+2K103284Laminoplasy Plating SystemAesculap Implant Systems, Inc.20101—
+2K100805Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC)20103—
+2K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+2K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.201017—
+2K091623Laminoplasty Fixation SystemNuvasive, Inc.20097—
+2K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+2K090354Laminoplasty Plating SystemAesculap Implant System, Inc.20092—
+2K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811—
+2K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+2K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+2K052152B-Bop PlateNew Deal, S.A.20051—
+2K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+2K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+2K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc.200517—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+3K252061Distal Xtremities SystemTriMed, Inc.20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+3K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+3K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221