510(k) Report

Devices descending from K961608

577 later devices reach Synthes (U.S.a.) Polypin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260405FiberTape ButtonArthrex, Inc.20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+8K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+8K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+8K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+8K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+8K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+8K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+8K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+8K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+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—
+8K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+8K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+8K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+8K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+8K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+8K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+8K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+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—
+8K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+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—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+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—
+8K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+8K202663Suture WingOsteonic Co., Ltd.20211—
+8K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+8K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+8K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, 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—
+8K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+8K183331Parcus GFS BTBParcus Medical, LLC20193—
+8K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—
+8K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+8K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+8K171465Stryker Self-Punching ICONIXStryker20171—
+8K160655OrthoButton CLRiverpoint Medical20169—
+8K152711Parcus GFS NakedParcus Medical, LLC20154—
+8K140769Variax 2 SystemStryker Trauma AG201419—
+8K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+8K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+9K262975Arthrex Beaming SystemArthrex, Inc.20260—
+9K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+9K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+9K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+9K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+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—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233659Suture WingOsteonic Co., Ltd.20230—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+9K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+9K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+9K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—