510(k) Report

Devices descending from K970089

82 later devices reach Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992458RC Multisuture Bone Anchor, Model 4453/4454Innovasive Devices, Inc.199979—
+1K992377RC TackInnovasive Devices, Inc.19991—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+2K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+2K994269Titan RC TackInnovasive Devices, Inc.20000—
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+3K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+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
+4K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+4K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+4K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+4K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+4K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+5K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+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—
+5K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+5K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+6K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+6K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+6K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+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—
+6K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+6K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+7K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+7K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+7K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+7K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+7K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+7K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+7K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+7K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+7K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+7K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+7K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+7K212739ActiFlipParcus Medical, LLC20210—
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+7K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K171465Stryker Self-Punching ICONIXStryker20171—
+7K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+7K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+8K244025Argo Knotless GENESYS AnchorConmed Corporation20251—
+8K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+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—
+8K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+8K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+9K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—