510(k) Report

Devices descending from K011118

361 later devices reach Normed Extremity Titanium Hand and Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+2K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K141489Linos Moh Hand Plating SystemKLS Martin L.P.20143—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+3K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+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—
+3K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+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—
+5K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K140376Variax 2 SystemStryker Trauma AG201423—
+5K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+5K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+5K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+5K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+5K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+5K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+5K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+5K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+5K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+5K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253906Xpert HandNewclip Technics20260—
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—