510(k) Report

Devices descending from K792022

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+8K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+8K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+8K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+8K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+8K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+8K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+8K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+8K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+8K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241235Arthrex TightRope IIArthrex, Inc.20243—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+8K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+8K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+8K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+8K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+8K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+8K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+8K220966SinefixBAAT Medical Products B.V.20231—
+8K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+8K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+8K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K202663Suture WingOsteonic Co., Ltd.20211—
+8K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+8K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+8K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+8K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+8K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+8K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+8K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+8K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+8K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+8K191972ARIX Wrist SystemJeil Medical Corporation20190—
+8K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+8K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+8K191009Arsenal Plating SystemTrilliant Surgical20192—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+8K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+8K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+8K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+8K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+8K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+8K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+8K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+8K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+8K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+8K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+8K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+8K171465Stryker Self-Punching ICONIXStryker20171—
+8K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl2017111
+8K162198GFS UltimateParcus Medical, LLC20168—
+8K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+8K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+8K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+8K140328CMC Mini TightropeArthrex, Inc.20146—
+8K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+8K132502Variax 2 SystemStryker Trauma AG201321—
+8K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+8K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+8K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+9K254280F.A.S.T ScrewSteps Ortho20260—
+9K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254215Arthrex Beaming SystemArthrex, Inc.20261—
+9K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+9K254176SinefixBAAT Medical Products B.V.20260—
+9K260405FiberTape ButtonArthrex, Inc.20260—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+9K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+9K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+9K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+9K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+9K242861TrueLok ElevateOrthofix Srl20243—
+9K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+9K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—
+9K232105APTUS Foot System 2.8-3.5Medartis AG20240—