510(k) Report

Devices descending from K954808

77 later devices reach Ussc Polyproplene Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133890Aesculap Optilene Nonabsorbable SutureAesculap, Inc.20145—
+1K050947Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc2005762
+2K180321Aesculap Optilene Nonabsorbable SutureAesculap, Inc.20180—
+2K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc.20163—
+2K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical2010152
+2K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical2007691
+3K232733Mbrace CableMedacta International S.A.20240—
+3K212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.20210—
+3K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+3K202242HS FiberRiverpoint Medical, LLC20200—
+3K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.20201—
+3K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+3K190817HS FiberRiverpoint Medical20196—
+3K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+3K173644Gazelle Polypropylene Suture and Delivery DeviceDura Tap, LLC20180—
+3K172016Force Fiber Fusion SutureTeleflex Medical Incorporated20171—
+3K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc20170—
+3K153307HS SutureTapeRiverpoint Medical20167—
+3K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+3K152795RiverLon (Nylon) SutureRiverpoint Medical20150—
+3K143356NovoStitch Plus Meniscal Repair SystemCeterix Orthopaedics, Inc.20152—
+3K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2Dunamis, LLC20150—
+3K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.201514—
+3K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K122336Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MMEleven Blade Solutions, Inc.20137—
+3K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC20100—
+3K094028CP-Fiber (Orthofiber)Cp Medical20100—
+3K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef200929—
+3K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092—
+3K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+3K071796Capsew Plication SystemCayenne Medical, Inc.20070—
+3K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.200723—
+4K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+4K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+4K253024ProZip Knotless ImplantRiverpoint Medical20250—
+4K231163HS Fiber SuturesRiverpoint Medical20243—
+4K230311HyperSutureThreadstone, LLC20234—
+4K221280VessealLydus Medical, Ltd.20220—
+4K210675EasyWhipWinter Innovations, Inc.20211—
+4K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+4K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation20190—
+4K180531NovoStitch Pro Meniscal Repair SystemCeterix Orthopaedics, Inc.20181—
+4K153746Dunamis Force DFX Tensile TapeDunamis, LLC20160—
+4K150584Stryker Suture TapeStryker20152—
+4K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K132513Q-Fix Suture Anchor,1.8MM and 2.8MM / Drill, Drill Guide and Obturator,1.8MM and 2.8MM…ArthroCare Corporation20136—
+4K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+4K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp.20121—
+4K112814CuffinkCayenne Medical, Inc.20120—
+4K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+5K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+5K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+5K252201HS FiberRiverpoint Medical20250—
+5K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+5K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+5K234079HyperSuture Extension LineThreadstone, LLC20240—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Ceterix Orthopaedics, Inc.20180—
+5K162310XBraid TT Suture TapeStryker20161—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K133727Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and…ArthroCare Corporation20145—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K172165Q-Fix Suture AnchorArthroCare Corporation20174—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+7K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…Smith & Nephew, Inc.20260—
+7K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…Smith & Nephew, Inc.20241—
+7K232457Q-FIX ULTRA All-Suture AnchorSmith & Nephew20230—
+7K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—