510(k) Report

Devices descending from K051296

836 later devices reach Sijf Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253202Hoffmann LRF SystemStryker GmbH20250—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242988Genostis Osteosynthesis SystemGenostis AF20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+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—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+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—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+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—
+5K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K202307Activ FuseNewclip Technics20200—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—