510(k) Report

Devices descending from K001941

800 later devices reach Synthes Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K243275Equinoxe® Scapula Fracture SystemExactech, Inc.20250—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K243469SignexOsteonic Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+3K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K230546SignexOsteonic Co., Ltd.20242—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+3K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+3K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+3K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K202803Activmotion S DTONewclip Technics20210—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+3K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+3K192984APTUS Clavicle SystemMedartis AG20206—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+3K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+3K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K170310Alians Clavicle rangeNewclip Technics20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—
+3K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+3K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+3K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K141548High Tibial Osteotomy SystemNewclip Technics20153—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+3K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K130774Universal Distal Radius SystemNewclip Technics20135—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K122623Short Lateral Superior Clavicle Plate, Left and Right Model 3017-000 (Left) and 3018-000…Advanced Orthopaedic Solutions, Inc.20120—