510(k) Report

Devices descending from K792022

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+9K233659Suture WingOsteonic Co., Ltd.20230—
+9K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+9K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+9K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+9K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+9K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+9K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+9K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+9K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+9K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+9K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+9K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+9K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+9K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+9K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+9K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+9K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+9K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+9K183331Parcus GFS BTBParcus Medical, LLC20193—
+9K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+9K172921Stryker Self-Punching ICONIXStryker20170—
+9K160655OrthoButton CLRiverpoint Medical20169—
+9K152711Parcus GFS NakedParcus Medical, LLC20154—
+9K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+9K140769Variax 2 SystemStryker Trauma AG201419—
+9K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+10K262975Arthrex Beaming SystemArthrex, Inc.20260—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+10K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+10K241912BiochargeNanofiber Solutions, LLC20240—
+10K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+10K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+10K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+10K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+10K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+10K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+10K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+10K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+10K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+10K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+10K173135VariAx 2 SystemStryker GmbH201713—
+10K171060OrthoButton ALRiverpoint Medical20178—
+10K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+11K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+11K253538TeKBrace Knotless AnchorTheramicro20260—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K253695LigaMendRiverpoint Medical, LLC20260—
+11K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+11K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+11K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+11K243988RootMend MRRRiverpoint Medical, LLC20250—
+11K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+11K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+11K240194ProCinch, QuadCinchRiverpoint Medical20240—
+11K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+11K233552IDEAL ZiploopRiverpoint Medical20230—
+11K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+11K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+11K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+11K230212OrthoButton ALRiverpoint Medical, LLC20232—
+11K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+11K202399OrthoButton FLRiverpoint Medical20201—
+11K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+11K180500VariAx 2 SystemStryker GmbH201812—
+12K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+12K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+12K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+12K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—