510(k) Report

Devices descending from K915889

80 later devices reach Mitek Bone Anchor, Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112417VariousDepuy Mitek, A Johnson & Johnson Company20120—
+1K111631Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Depuy Mitek, A Johnson & Johnson Company20111—
+1K041115Gii Quickanchor PlusDepuy Mitek, A Johnson & Johnson Company2004141
+1K992611Mitek Rotator Cuff Quickanchor PlusMitek Products19994—
+1K981755LM AnchorLi Medical Technologies, Inc.19980—
+1K960439LM Bone AnchorLi Medical Technologies, Inc.199660—
+2K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+2K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…Cayenne Medical, Inc.20117—
+2K070773Axya, Model 3000 Axyzloop Titanium Bone AnchorAxya Medical, Inc.20070—
+2K052630Rotator Cuff Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company20052—
+2K051989Gii Quickanchor Plus with Orthocord SutureDepuy Mitek, A Johnson & Johnson Company20053—
+2K993575Resolve QuickanchorMitek Products19990—
+2K963288LM Bone AnchorLi Medical Technologies, Inc.19960—
+2K963812LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc.199658—
+3K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+3K110800Meta-Lock Suture Anchor SystemTarsus Medical, Inc.20110—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+3K013553Pre-Loaded Ultrafix RCLinvatec Corp.20010—
+4K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+4K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+4K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+4K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+4K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+4K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+4K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+5K220757Argo Knotless SP AnchorConmed Corporation20226—
+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—
+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—
+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—
+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—
+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—
+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—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+8K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—