510(k) Report

Devices descending from K961608

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+6K253115Lars AcjMovmedix S.A.S.20260—
+6K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K251134RipCordTriMed, Inc.20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+6K242091Bolo Button SystemFusion Orthopedics20240—
+6K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+6K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+6K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K230546SignexOsteonic Co., Ltd.20242—
+6K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K231857Arthrex TightRope IIArthrex, Inc.20234—
+6K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+6K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+6K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+6K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+6K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K211049Tigon Medical Button SystemTigon Medical20210—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+6K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+6K192984APTUS Clavicle SystemMedartis AG20206—
+6K191426FiberTak ButtonArthrex, Inc.20190—
+6K190143LARS AC Band DeviceCorin USA20191—
+6K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K191204Infinity Fixation SystemConmed Corporation20190—
+6K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+6K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+6K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+6K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+6K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+6K180759SECULOK™ Suture AnchorU&I Corporation20180—
+6K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+6K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173278ToggleLoc SystemBiomet, Inc.20183—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+6K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+6K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+6K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+6K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+6K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+6K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+6K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+6K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+6K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+6K133304RXG Distraction SystemKLS-Martin L.P.20140—
+6K133275Mini TightropeArthrex, Inc.201411—
+6K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+6K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+6K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+6K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+6K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+6K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+6K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+6K111032CMC Cable FixInstratek, Inc.20112—
+6K101484Compressyn BandDallen Medical20115—
+6K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+6K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+6K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+6K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—