510(k) Report

Devices descending from K974309

167 later devices reach Lactosorb Panels through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041835Endotine Midface B 4.5 DeviceCoapt Systems, Inc.20040—
+1K030425Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc.20041—
+1K040740Endotine Transbleph DeviceCoapt Systems, Inc.20042—
+1K033524Coapt Endotine Chin 3.5 DeviceCoapt Systems, Inc.20033—
+1K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc.200374—
+1K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+1K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+2K133304RXG Distraction SystemKLS-Martin L.P.20140—
+2K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+2K060248Ultratine TransblephCoapt Systems, Inc.20060—
+2K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+2K051236Resorb-X SFKLS-Martin L.P.20056—
+2K042796Endotine Transbleph 3.0/3.5 DeviceCoapt Systems, Inc.200401
+2K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+2K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp200472—
+2K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+2K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+2K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+3K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+3K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+3K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+3K121606Resorb-X GKLS-Martin L.P.20130—
+3K112064Resorb X-GKLS-Martin L.P.20122—
+3K113109Stryker Resorbable Fixation SystemStryker20113—
+3K091061Implicitguide Surgical Suture SystemImplicitcare, LLC20091—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+3K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+3K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+3K052962Optimized Barb DesignSurgical Specialties Corp20050—
+3K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp200565—
+3K050247Contour Necklift ThreadsSurgical Specialties Corp20053—
+3K042856Contour Forehead/Browlift ThreadSurgical Specialties Corp20044—
+3K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+4K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K230510MyEllevateCynosure, LLC20230—
+4K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+4K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+4K142484Sternal Closure SystemJace Medical, LLC20141—
+4K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+4K101484Compressyn BandDallen Medical20115—
+4K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+4K052373Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc.200510—
+4K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.200564—
+4K051415Endotine RibbonCoapt Systems, Inc.20051—
+5K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+5K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+5K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+5K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+5K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+5K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+5K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A.20171—
+5K133420Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech20136—
+5K130431Compressyn BandDallen Medical, Inc.20134—
+5K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+5K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+5K120827Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech201213—
+5K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech201225—
+5K113800Quill Quadrahelix Tissue-Closure DeviceAngiotech20123—
+5K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+5K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp200829—
+5K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp200830—
+5K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp200731—
+5K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+5K060828Modification to Endotine RibbonCoapt Systems, Inc.20060—
+5K053380Contour Thread Synthetic Absorbable Pdo Barbed SutureSurgical Specialties Corp20063—
+5K052900Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc.20050—
+6K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+6K253879Monofix PdoSamyang Holdings Corporation20260—
+6K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+6K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+6K233355Cypris eXact Suturing SystemCypris Medical20240—
+6K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+6K211178DURAMESH Mesh SutureMsi20220—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K210871PDO Max Suture with Dual NeedlePdo Max, Inc.20210—
+6K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+6K202950StitchKit COMBOOrigami Surgical20212—
+6K201139WEGO-PDO Barbed SutureFoosin Medical Supplies Inc., Ltd.20200—
+6K192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC20200—
+6K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+6K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+6K190264ViolaMeditime Co., Ltd.20190—
+6K172602MiracuFeeltech Co., Ltd.20184—
+6K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc.20160—
+6K143413J+PRAS YOUNG'S ThreadY. Jacobs Medical, Inc.20150—
+6K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+6K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc.20158—
+6K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+6K133858Tensyn BandDallen Medical, Inc.20143—
+6K132268Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation Dba Angiotech20130—
+6K130191MINTHans Biomed Corporation20135—
+6K123877Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201311—
+6K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+6K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191