510(k) Report

Devices descending from K943806

47 later devices reach Harpoon Suture Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+1K012469Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc.20014—
+1K012872Resorbable Screw AnchorArthrotek, Inc.200130—
+1K012503Metal Screw AnchorBiomet Manufacturing, Inc.200117—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+2K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+2K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+2K071816Harpoon Suture AnchorBiomet Sports Medicine, Inc.20070—
+2K042460TI - Screw Anchor SPArthrotek, Inc.20047—
+2K041274Resorbable Interference ScrewArthrotek, Inc.2004265
+2K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc.20048—
+2K032072Lactosorb L15 Screw Anchor with Lactocarbonate SutureArthrotek, Inc.20030—
+2K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc.20023—
+3K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+3K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+3K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+3K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+3K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+3K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine201112
+3K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc.200791
+3K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY20071—
+3K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc.20067—
+3K061389Allthread Lactosorb Suture AnchorArthrotek, Inc.20067—
+3K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc.20050—
+3K042552Bio-Core Interference ScrewBiomet, Inc.20044—
+3K033233Lactosorb Tibial L-15 Screw and WasherBiomet, Inc.20032—
+4K193092TunneLoc Tibial Fixation DeviceBiomet, Inc.20200—
+4K152262Ventix Knotless AnchorsBiomet Manufacturing Corp20160—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+4K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+4K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+4K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc.20117—
+5K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+5K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+5K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+5K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc.20115—
+6K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends…Jarmon Medical, LLC (Dba Legends Orthopedics)20230—
+6K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+6K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+7K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—