510(k) Report

Devices descending from K963172

722 later devices reach Synthes Sterile 4.5 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+4K192984APTUS Clavicle SystemMedartis AG20206—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K190143LARS AC Band DeviceCorin USA20191—
+4K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K191204Infinity Fixation SystemConmed Corporation20190—
+4K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K173641Activ AnkleNewclip Technics20183—
+4K173278ToggleLoc SystemBiomet, Inc.20183—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+4K133275Mini TightropeArthrex, Inc.201411—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+4K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K111032CMC Cable FixInstratek, Inc.20112—
+4K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+4K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—