510(k) Report

Devices descending from K903810

889 later devices reach Ace Cannulated Self Tapping Cancellous Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230817TORPEDO Implant System®Deltacor GmbH20240—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K231831TiLink-L Joint Fusion SystemSurgentec20232—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K213815SiJoin®T3Vgi Medical, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K222448UNITY Sacroiliac Joint Fixation SystemDio Medical Corporation20222—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+4K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K200868SI-Restore Sacroiliac Joint Fixation SystemBiofusion Medical20200—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+4K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—