510(k) Report

Devices descending from K792022

988 later devices reach Herbert Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231857Arthrex TightRope IIArthrex, Inc.20234—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+7K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+7K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+7K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+7K221395Footmotion Plating SystemNewclip Technics20220—
+7K220757Argo Knotless SP AnchorConmed Corporation20226—
+7K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K213214Xpert WristNewclip Technics20210—
+7K212739ActiFlipParcus Medical, LLC20210—
+7K211049Tigon Medical Button SystemTigon Medical20210—
+7K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+7K202810AutoStrut G2Orthospin, Ltd.20213—
+7K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+7K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+7K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+7K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+7K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+7K192984APTUS Clavicle SystemMedartis AG20206—
+7K193606Y-Knot OneStep AnchorConmed Corporation20200—
+7K191426FiberTak ButtonArthrex, Inc.20190—
+7K190143LARS AC Band DeviceCorin USA20191—
+7K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+7K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+7K191204Infinity Fixation SystemConmed Corporation20190—
+7K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+7K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+7K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+7K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+7K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+7K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+7K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+7K173641Activ AnkleNewclip Technics20183—
+7K173278ToggleLoc SystemBiomet, Inc.20183—
+7K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+7K171725CuffLink Implant SystemConmed Corporation20170—
+7K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170843Alians Fragment SpecificNewclip Technics20171—
+7K170771VariAx 2 Foot SystemStryker GmbH20170—
+7K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+7K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+7K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+7K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+7K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+7K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+7K151769Anchorage 2 CP SystemStryker GmbH20150—
+7K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+7K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+7K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+7K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+7K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+7K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+7K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+7K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+7K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+7K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+7K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+7K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+7K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+7K133275Mini TightropeArthrex, Inc.201411—
+7K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+7K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+7K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+7K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+7K111032CMC Cable FixInstratek, Inc.20112—
+7K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+7K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+7K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+7K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+8K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+8K254182AsterOsteonic Co., Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—