510(k) Report

Devices descending from K000540

261 later devices reach Polyester Nonabsorbable Surgical Sutures, Usp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+6K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+6K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+6K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+6K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+6K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+6K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+7K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+7K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…Smith & Nephew, Inc.20260—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+7K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…Smith & Nephew, Inc.20241—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+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—
+7K220966SinefixBAAT Medical Products B.V.20231—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+7K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+7K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+7K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+7K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+7K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+7K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K183331Parcus GFS BTBParcus Medical, LLC20193—
+7K160655OrthoButton CLRiverpoint Medical20169—
+7K152711Parcus GFS NakedParcus Medical, LLC20154—
+8K254176SinefixBAAT Medical Products B.V.20260—
+8K253538TeKBrace Knotless AnchorTheramicro20260—
+8K253695LigaMendRiverpoint Medical, LLC20260—
+8K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+8K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+8K243988RootMend MRRRiverpoint Medical, LLC20250—
+8K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+8K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+8K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+8K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+8K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+8K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+8K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+8K171060OrthoButton ALRiverpoint Medical20178—
+9K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+9K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+9K240194ProCinch, QuadCinchRiverpoint Medical20240—
+9K233552IDEAL ZiploopRiverpoint Medical20230—
+9K230212OrthoButton ALRiverpoint Medical, LLC20232—
+9K202399OrthoButton FLRiverpoint Medical20201—
+10K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—