510(k) Report

Devices descending from K011815

185 later devices reach Synthes LCP Proximal Humerus Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+1K233994VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbH20240—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+1K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+1K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.20181—
+1K172008ARIX Humerus SystemJeil Medical Corporation20173—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K121826Integra Proximal Humeral Plate SystemAscension Orthopedics, Inc.20130—
+1K121495Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, LongAap Implantate AG20122—
+1K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc.201220—
+1K120108Aptus Proximal Humerus SystemMedartis AG20122—
+1K112663Enhatch Orthopaedics Patient/Technique-Specific HumeralEnhatch Orthopaedics, LLC20120—
+1K110700Ascension Atlas Humeral Plating SystemAscension Orthopedics, Inc.20111—
+1K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+1K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.20104—
+1K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+1K080590Aos Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.20082—
+1K062494Ebi Optilock Upper Extremity Plating SystemEbi, L.P.2006221
+1K051412Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200521
+1K042695NCB Plating SystemZimmer GmbH2004681
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+2K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K230938ARIX Humerus SystemJeil Medical Corporation20230—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K211582LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG20211—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH201911—
+2K192021NCB Polyaxial Locking Plate SystemZimmer GmbH20191—
+2K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K181425APTUS® Proximal Humerus SystemMedartis AG20181—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+2K160995NEOVIEW Plating SystemIn2bones Sas201624
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+2K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.20161—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+2K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Shoulder Options, Inc.201416—
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+2K110201Explor Radial Head Plating SystemBiomet, Inc.20110—
+2K110320Comprehensiveproximal Humeral Plating SystemBiomet Manufacturing Corp20110—
+2K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010—
+2K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+2K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH2008212
+2K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH2006254
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—