510(k) Report

Devices descending from K963546

460 later devices reach SMF Titanium (TI) Alloy Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+9K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+9K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+9K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+9K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K200226RetroFixRetrofix Screws, LLC20200—
+9K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K191867ATLAS Plating SystemMiRus, LLC20200—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+9K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+9K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+9K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+9K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+9K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+9K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+9K190830TDM Screw SystemsTdm Co., Ltd.20191—
+9K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+9K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+9K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+9K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+9K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+9K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+9K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+9K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+9K173641Activ AnkleNewclip Technics20183—
+9K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+9K172350AxSOS 3 TiStryker GmbH201717—
+9K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+9K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+9K171510Footmotion Plating SystemNewclip Technics20171—
+9K170843Alians Fragment SpecificNewclip Technics20171—
+9K170771VariAx 2 Foot SystemStryker GmbH20170—
+9K170012Foot and Hand MotionNewclip Technics20170—
+9K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+9K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+9K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+9K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+9K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+9K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+9K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+9K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+9K151769Anchorage 2 CP SystemStryker GmbH20150—
+9K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+9K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+9K143092Tensyn PlugDallen Medical, Inc.20151—
+9K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+9K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+9K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+10K262344Large Compression ScrewsTriMed, Inc.20260—
+10K261511Xpert AnkleNewclip Technics20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260810Anteralign LS coverplateTyber Medical, LLC20260—
+10K260761APTUS Clavicle System 2.8Medartis AG20260—
+10K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+10K261241TriMed Compression ScrewsTriMed, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+10K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+10K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+10K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+10K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+10K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+10K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+10K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+10K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+10K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+10K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+10K231860TDM Screw SystemTdm Co., Ltd.20240—
+10K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+10K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—