510(k) Report

Devices descending from K992961

378 later devices reach Lorenz Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+8K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+8K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+8K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+8K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+8K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+8K231860TDM Screw SystemTdm Co., Ltd.20240—
+8K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+8K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+8K233017TM Plating SystemTyber Medical, LLC20231—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+8K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+8K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+8K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+8K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+8K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+8K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+8K211843PolyLock Plating SystemFusion Orthopedics20220—
+8K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+8K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+8K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+8K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K181091AxSOS 3 TiStryker GmbH201811—
+8K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+8K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+8K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+8K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+9K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+9K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+9K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+9K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+9K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+10K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+10K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+10K143092Tensyn PlugDallen Medical, Inc.20151—
+11K252246Leforte MMF SystemJeil Medical Corporation20260—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+11K150359Tensyn PlugDallen Medical, Inc.20150—