510(k) Report

Devices descending from K962011

738 later devices reach Synthes 7.0/7.3 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250647SImmetry+ SystemSivantage20250—
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K230546SignexOsteonic Co., Ltd.20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+4K213815SiJoin®T3Vgi Medical, Inc.20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+4K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—