510(k) Report

Devices descending from K920213

109 later devices reach Mitek Anchor, Mitek Anchor II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981677Repose Bone Screw SystemInfluence, Inc.1999162
+1K980595Depuy Orthotech Catera Suture AnchorDePuy Orthopaedics, Inc.19980—
+1K972023Sleep-in Bone Screw SystemInfluence, Inc.199723—
+1K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc.1997401
+1K962372Urotac Bone Anchor InserterInfluence, Inc.199644—
+1K960825LM Anchor or Other Proprietary NameLi Medical Technologies, Inc.199661—
+1K960439LM Bone AnchorLi Medical Technologies, Inc.199660—
+2K122391Medtronic Xomed, Inc.Medtronic Xomed, Inc.20134—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+2K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc.201015—
+2K040417Pillar Palatal Implant SystemRestore Medical, Inc.20040—
+2K011723Anti-Snoring Device or AsdPi Medical20024—
+2K011910IN-Fast Bone Screw SystemAmerican Medical Systems, Inc.20010—
+2K972622Straight-in Bone Screw Fixation SystemInfluence, Inc.199714—
+2K964953IN-Tac Bone Anchor SystemInfluence, Inc.19972—
+2K963288LM Bone AnchorLi Medical Technologies, Inc.19960—
+2K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.199658—
+3K183310Encore SystemSiesta Medical, Inc.20192—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K133680Encore SystemSiesta Medical, Inc.20143—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K110623Pillar Palatal Implant SystemMedtronic Xomed, Inc.20122—
+3K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc.201014—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+3K020446Modification to Straight-in Bone Screw Fixation SystemAmerican Medical Systems, Inc.20020—
+3K013553Pre-Loaded Ultrafix RCLinvatec Corp.20010—
+3K990160Microtac-Bone Anchor SystemInfluence, Inc.19991—
+3K982155Short Straight-in Bone Screw Fixation SystemInfluence, Inc.199812—
+4K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+4K201238Encore SystemSiesta Medical, Inc.20201—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+4K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc.20181—
+4K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.201113—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+4K992277Stapletac Bone Anchor SystemInfluence, Inc.19990—
+4K990095Straight-in-Orthopedic Bone Screw Fixation SystemInfluence, Inc.19990—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+5K220757Argo Knotless SP AnchorConmed Corporation20226—
+5K213475Elevo Snoring Intervention SetZelegent, Inc.20220—
+5K213159Encore SystemSiesta Medical, Inc.20210—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+5K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+5K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K171725CuffLink Implant SystemConmed Corporation20170—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc.20116—
+5K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+5K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+6K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+6K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+6K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+6K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+6K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+6K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+6K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+6K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124—
+6K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120—
+6K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+6K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+7K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+7K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+7K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+7K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+7K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K171465Stryker Self-Punching ICONIXStryker20171—
+7K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+7K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+8K233659Suture WingOsteonic Co., Ltd.20230—