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
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+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—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172008ARIX Humerus SystemJeil Medical Corporation20173—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K170705ARIX Wrist SystemJeil Medical Corporation20172—
+4K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+4K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+4K143721PRCT2Fx Solutions20150—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150469Integra Laminoplasty SystemSeaspine, Inc.20151—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+4K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+4K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+4K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+4K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+4K131061Restore Bunion Correction SystemNextremity Solutions201315—
+4K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+4K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+4K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+4K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—