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
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241539Activmotion SNewclip Technics20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+6K213214Xpert WristNewclip Technics20210—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203381Dynanail Mini HybridMedShape, Inc.202141
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K202810AutoStrut G2Orthospin, Ltd.20213—
+6K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+6K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193366T2 ICFStryker GmbH20201—
+6K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+6K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+6K190230iFuse Implant System®SI-BONE, Inc.201957—
+6K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K173641Activ AnkleNewclip Technics20183—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172350AxSOS 3 TiStryker GmbH201717—
+6K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170843Alians Fragment SpecificNewclip Technics20171—
+6K170771VariAx 2 Foot SystemStryker GmbH20170—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+6K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+6K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—