FDA 510(k) Applications for Medical Device Product Code "HTN"
(Washer, Bolt Nut)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243624 | Acumed LLC | Acu-Sinch Knotless Mini | 01/23/2025 |
| K112111 | ACUMED LLC | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR | 11/14/2011 |
| K212990 | Acumed LLC | Acumed Ankle Syndesmosis Repair System | 01/07/2022 |
| K130986 | ACUMED LLC | FRAG-LOC SYSTEM | 07/23/2013 |
| K965028 | ACUMED, INC. | ACUMED SUTURE WASHER | 03/17/1997 |
| K954148 | ACUMED, INC. | SUTURE WASHER | 01/17/1996 |
| K162805 | Akros Medical | Akros Fibulink Syndesmosis Repair Kit | 01/10/2017 |
| K173550 | Akros Medical | Akros FibuLinkÖ Syndesmosis Repair Kit | 12/14/2017 |
| K200361 | Akros Medical | Akros Scruture Anchor LisFranc Repair Kit | 04/06/2020 |
| K221485 | Arthrex Inc. | Arthrex FiberTape and TigerTape Cerclage Sutures | 08/22/2022 |
| K232755 | Arthrex Inc. | Arthrex FiberTape and TigerTape Cerclage Sutures | 10/06/2023 |
| K220947 | Arthrex Inc. | Arthrex Knotless AC Repair Devices | 06/06/2022 |
| K213644 | Arthrex Inc. | Arthrex Knotless Mini TightRopes | 12/17/2021 |
| K201522 | Arthrex Inc. | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | 09/03/2020 |
| K112437 | ARTHREX, INC. | ARTHREX FRACTURE SYSTEM | 12/21/2011 |
| K023119 | ARTHREX, INC. | BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B | 12/18/2002 |
| K043145 | ARTHREX, INC. | BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B | 02/18/2005 |
| K140328 | ARTHREX, INC. | CMC MINI TIGHTROPE | 03/10/2014 |
| K133275 | ARTHREX, INC. | MINI TIGHTROPE | 01/30/2014 |
| K090107 | ARTHREX, INC. | MINI TIGHTROPE | 08/06/2009 |
| K071978 | ARTHREX, INC. | MINI TIGHTROPE FT REPAIR KIT | 08/15/2007 |
| K061925 | ARTHREX, INC. | MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS | 10/31/2006 |
| K052776 | ARTHREX, INC. | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | 12/13/2005 |
| K043248 | ARTHREX, INC. | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | 02/16/2005 |
| K170440 | Arthrosurface, Inc | KISSloc Suture System | 05/03/2017 |
| K133835 | ARTHROSURFACE, INC. | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | 07/03/2014 |
| K141219 | BIOMET MANUFACTURING CORP. | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS | 07/18/2014 |
| K132510 | BIOPRO, INC. | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | 10/24/2013 |
| K232780 | CC-Instruments Inc | CC-Clip« Implant System | 12/18/2023 |
| K190516 | CONMED Corporation | MicroLink All-Suture Button Fixation System (Radiolucent) | 06/28/2019 |
| K190582 | CONMED Corporation | MicroLink All-Suture Button Fixation System (Radiopaque) | 06/28/2019 |
| K153211 | CORACOID SOLUTIONS, INC. | M-Fix Acromioclavicular Device | 02/02/2016 |
| K190143 | Corin USA | LARS AC Band Device | 11/04/2019 |
| K183094 | Cycla Orthopedics Ltd | CyclaPlex Correction System | 04/26/2019 |
| K131850 | DALLEN MEDICAL, INC. | TENSYN BAND | 11/15/2013 |
| K133858 | DALLEN MEDICAL, INC. | TENSYN BAND | 02/28/2014 |
| K141264 | DALLEN MEDICAL, INC. | TENSYN BAND, TENSYN FRACTURE PLATES | 08/21/2014 |
| K143092 | DALLEN MEDICAL, INC. | Tensyn Plug | 02/11/2015 |
| K150359 | DALLEN MEDICAL, INC. | Tensyn Plug | 05/07/2015 |
| K983265 | DEPUY ACE MEDICAL CO. | DEPUY ACE COMPOSITE LOCKING NUT | 10/26/1998 |
| K983906 | DEPUY ORTHOPAEDICS, INC. | DEPUY ORTHOTECH SPIKED WASHER | 12/18/1998 |
| K991135 | DEPUY, INC. | SOFT TISSUE SUTURE WASHER | 04/29/1999 |
| K242091 | Fusion Orthopedics | Bolo Button System | 12/23/2024 |
| K240947 | Globus Medical, Inc | TENSOR« Suture Button System | 06/03/2024 |
| K200332 | GM dos Reis Industria e Comercio Ltda | EXPERT - Joint Fixation System | 10/29/2020 |
| K242311 | GM dos Reis Industria e Comercio Ltda. | EXPERT - Flexible Joint Fixation System | 11/01/2024 |
| K220260 | In2Bones USA, LLC | Hercules Syndesmosis Implant System | 03/31/2022 |
| K111032 | INSTRATEK, INC. | CMC CABLE FIX | 08/31/2011 |
| K082384 | INSTRATEK, INC. | HAV-LOK BUNION CORRECTION SYSTEM | 12/08/2008 |
| K091763 | INSTRATEK, INC. | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 | 08/14/2009 |
| K954682 | LINVATEC CORP. | WASHER, BOLT, NUT, ORTHOPEDIC | 02/09/1996 |
| K211612 | Medline Industries, Inc. | Medline UNITE REFLEX Dynamic Discs | 12/10/2021 |
| K141420 | MEDSHAPE, INC | FASTFORWARD | 12/18/2014 |
| K172620 | Mortise Medical LLC | SyndesMetrics Syndesmosis Repair System | 11/08/2017 |
| K132733 | ORTHOHELIX SURGICAL DESIGNS, INC. | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | 01/03/2014 |
| K963420 | ORTHOPAEDIC BIOSYSTEMS, LTD. | CANCELLOUS SCREW WASHER | 11/15/1996 |
| K233531 | Orthopaedic Implant Company | OIC FLEX-FIXÖ System | 02/02/2024 |
| K030619 | ORTHOPEDIC DESIGNS, INC. | ODI 7.0MM CANNULATED SCREW SYSTEM | 04/01/2003 |
| K171703 | Panther Orthopedics, Inc. | PUMA System | 03/01/2018 |
| K003496 | PIONEER SURGICAL TECHNOLOGY | CANNULATED SCREW SYSTEM | 02/08/2001 |
| K992617 | PIONEER SURGICAL TECHNOLOGY | HEX BUTTON | 10/27/1999 |
| K043411 | RESOFIX, INC. | RESOFIX BIOABSORBABLE EXPANSION BOLT | 02/17/2005 |
| K082095 | SMITH & NEPHEW ENDOSCOPY, INC. | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | 10/21/2008 |
| K162996 | SMITH & NEPHEW, INC. | INVISIKNOT Ankle Syndesmosis Repair Kit | 06/08/2017 |
| K183232 | Smith and Nephew, Inc. | Double ENDOBUTTON Fixation Device | 03/12/2019 |
| K982354 | SPECIAL DEVICES, INC. | SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M | 11/23/1998 |
| K091207 | SURGICRAFT LTD. | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | 02/15/2011 |
| K011583 | SYNTHES (USA) | SPIKED WASHER | 01/30/2002 |
| K013806 | SYNTHES (USA) | SYNTHES METALLIC SPIKED WASHERS | 02/08/2002 |
| K980944 | SYNTHES (USA) | SYNTHES SCHUHLI IMPLANT SYSTEM | 04/27/1998 |
| K040250 | TRIAGE MEDICAL INC | BONE-LOK HP WASHER | 03/23/2004 |
| K251134 | TriMed, Inc. | RipCord | 07/11/2025 |
| K220650 | TriMed, Inc. | TriMed Ripcord Device | 06/01/2022 |
| K240035 | Vilex LLC | TACTIX Vector Syndesmosis System | 08/01/2024 |
| K243408 | Vilex LLC | TACTIX Vector Syndesmosis System | 11/27/2024 |
| K170249 | WRIGHT MEDICAL TECHNOLOGY, INC. | GRAVITYÖ Syndesmosis LP | 06/30/2017 |
| K180243 | Xiros Ltd | Infinity-Lock Button System | 04/03/2018 |
| K091799 | ZIMMER, INC. | CABLE READY CABLE GRIP SYSTEM CABLE BUTTON | 09/11/2009 |
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