510(k) Report

Devices descending from K920738

346 later devices reach Ace 100 Degrees Tubular Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+2K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+3K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+3K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+3K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+3K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+4K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+4K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+4K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+4K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+4K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+4K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+4K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253906Xpert HandNewclip Technics20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242988Genostis Osteosynthesis SystemGenostis AF20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+5K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—