510(k) Report

Devices descending from K061748

157 later devices reach Fragment Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+1K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K1318672.5MM Inline Fusion PlateBiomet, Inc.20130—
+1K131670Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)Biomet, Inc.20135—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…DePuy Orthopaedics, Inc.2010154—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc.201845
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K173135VariAx 2 SystemStryker GmbH201713—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K140376Variax 2 SystemStryker Trauma AG201423—
+2K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K200785Stratum™ Reduced Size Foot Plating SystemNextremity Solutions, Inc.20200—
+3K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180500VariAx 2 SystemStryker GmbH201812—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K141992Variax 2 SystemStryker Trauma AG201422—
+3K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170771VariAx 2 Foot SystemStryker GmbH20170—
+4K161448Footmotion Plating SystemNewclip Technics20165—
+4K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+4K151769Anchorage 2 CP SystemStryker GmbH20150—
+4K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+4K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+4K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+5K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+5K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—