510(k) Report

Devices descending from K931519

50 later devices reach Acufex Suretac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023417Suretac Iii, Models 7209900, 7209901Smith & Nephew, Inc.20020—
+1K020948Smith & Nephew Suretac - Expanded Indications IISmith & Nephew, Inc.20021—
+1K012572Soft Tissue Screw and WasherBiomet, Inc.200147—
+2K081172Composite Hitch Suture AnchorBiomet Manufacturing Corp20080—
+2K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+2K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc.200791
+2K061657Hitch Lactosorb Suture AnchorArthrotek, Inc.20068—
+2K041274Resorbable Interference ScrewArthrotek, Inc.2004265
+2K040475Micromax Suture AnchorBiomet, Inc.200471
+2K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc.200415—
+3K152262Ventix Knotless AnchorsBiomet Manufacturing Corp20160—
+3K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+3K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc.20117—
+3K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine201112
+3K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+3K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+3K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY20071—
+3K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc.20067—
+3K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+3K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.200513—
+3K042552Bio-Core Interference ScrewBiomet, Inc.20044—
+4K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+4K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+4K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+4K193092TunneLoc Tibial Fixation DeviceBiomet, Inc.20200—
+4K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+4K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+4K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+4K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+4K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+4K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials20073—
+5K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+5K203335MectaScrew ExtensionMedacta International S.A.20220—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+5K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+5K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+5K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+5K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+5K092998Conmed Linvatec Intercept ImplantLinvatec Corp.20090—
+6K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—