510(k) Report

Devices descending from K950045

438 later devices reach KLS-Martin Mandibular Fracture/Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190830TDM Screw SystemsTdm Co., Ltd.20191—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+8K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+8K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+8K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+8K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+8K173641Activ AnkleNewclip Technics20183—
+8K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+8K172350AxSOS 3 TiStryker GmbH201717—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+8K171510Footmotion Plating SystemNewclip Technics20171—
+8K170843Alians Fragment SpecificNewclip Technics20171—
+8K170771VariAx 2 Foot SystemStryker GmbH20170—
+8K170012Foot and Hand MotionNewclip Technics20170—
+8K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+8K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+8K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+8K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+8K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+8K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+8K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+8K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+8K151769Anchorage 2 CP SystemStryker GmbH20150—
+8K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+8K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+8K143092Tensyn PlugDallen Medical, Inc.20151—
+8K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+8K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+8K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K262344Large Compression ScrewsTriMed, Inc.20260—
+9K261511Xpert AnkleNewclip Technics20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K260761APTUS Clavicle System 2.8Medartis AG20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K261241TriMed Compression ScrewsTriMed, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+9K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+9K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+9K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+9K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+9K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+9K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+9K231860TDM Screw SystemTdm Co., Ltd.20240—
+9K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+9K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+9K233017TM Plating SystemTyber Medical, LLC20231—
+9K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+9K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+9K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+9K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+9K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+9K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+9K211843PolyLock Plating SystemFusion Orthopedics20220—
+9K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+9K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+9K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+9K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+9K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—