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
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250647SImmetry+ SystemSivantage20250—
+5K242988Genostis Osteosynthesis SystemGenostis AF20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—