510(k) Report

Devices descending from K901456

399 later devices reach Orthosorb (R) Absorbable Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+8K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+8K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+8K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+8K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+8K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+8K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+8K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+8K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+8K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+8K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+8K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+8K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+8K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+8K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+8K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+8K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+8K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+8K183331Parcus GFS BTBParcus Medical, LLC20193—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K160655OrthoButton CLRiverpoint Medical20169—
+8K152711Parcus GFS NakedParcus Medical, LLC20154—
+8K140769Variax 2 SystemStryker Trauma AG201419—
+9K262975Arthrex Beaming SystemArthrex, Inc.20260—
+9K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+9K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+9K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+9K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+9K173135VariAx 2 SystemStryker GmbH201713—
+9K171060OrthoButton ALRiverpoint Medical20178—
+9K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+10K253538TeKBrace Knotless AnchorTheramicro20260—
+10K253695LigaMendRiverpoint Medical, LLC20260—
+10K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+10K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+10K243988RootMend MRRRiverpoint Medical, LLC20250—
+10K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+10K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+10K240194ProCinch, QuadCinchRiverpoint Medical20240—
+10K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+10K233552IDEAL ZiploopRiverpoint Medical20230—
+10K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+10K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+10K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+10K230212OrthoButton ALRiverpoint Medical, LLC20232—
+10K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+10K202399OrthoButton FLRiverpoint Medical20201—
+10K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+10K180500VariAx 2 SystemStryker GmbH201812—
+11K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+11K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+11K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+11K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+11K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+11K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+12K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+13K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+13K233919VariAx 2 Distal Radius SystemStryker GmbH20242—