510(k) Report

Devices descending from K003227

526 later devices reach Bio-Absorbable Corkscrew Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+6K240213Iconix Knotless AnchorRiverpoint Medical20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+6K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+6K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+6K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K202663Suture WingOsteonic Co., Ltd.20211—
+6K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+6K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K192810Apollo Suture Anchor SystemValeris Medical20201—
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+6K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K172921Stryker Self-Punching ICONIXStryker20170—
+6K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K171060OrthoButton ALRiverpoint Medical20178—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+6K152255BoneCam Suture AnchorsValeris Medical20151—
+6K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+6K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+6K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+7K262975Arthrex Beaming SystemArthrex, Inc.20260—
+7K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K260405FiberTape ButtonArthrex, Inc.20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+7K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+7K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+7K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+7K241577Iconix® AnchorRiverpoint Medical20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240194ProCinch, QuadCinchRiverpoint Medical20240—
+7K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+7K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+7K233659Suture WingOsteonic Co., Ltd.20230—
+7K233552IDEAL ZiploopRiverpoint Medical20230—
+7K233468Iconix AnchorRiverpoint Medical20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+7K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+7K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+7K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+7K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+7K230212OrthoButton ALRiverpoint Medical, LLC20232—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K202399OrthoButton FLRiverpoint Medical20201—
+7K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+7K180500VariAx 2 SystemStryker GmbH201812—
+7K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+7K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+8K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+8K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—