Washer, Bolt Nut
FDA product code HTN · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
93510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Arthrex, Inc. 16
- Synthes (Usa) 5
- Dallen Medical, Inc. 5
- Acumed LLC 4
- Acu Med, Inc. 4
- Buckman Co., Inc. 3
- Instratek, Inc. 3
- Akros Medical 3
- Depuy, Inc. 2
- Conmed Corporation 2
- TriMed, Inc. 2
- Vilex, LLC 2
- Pioneer Surgical Technology 2
- GM Dos Reis Industria e Comercio Ltda. 2
- Arthrosurface, Inc. 2
- Special Devices, Inc. 1
- Movmedix S.A.S. 1
- DePuy Orthopaedics, Inc. 1
- Orthopaedic Biosystems, Ltd. 1
- Linvatec Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
| K252081 | SportLinc Syndesmosis DeviceHTN · Traditional | Lincotek Medical | 03/27/2026SE |
| K253727 | Syndesmosis TightRope PROHTN · Special | Arthrex, Inc. | 12/22/2025SE |
| K251643 | Synchfix EVTHTN · Traditional | Wright Medical Technology, Inc. (Stryker… | 10/29/2025SE |
| K251134 | RipCordHTN · Traditional | TriMed, Inc. | 07/11/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | Acumed, LLC | 01/23/2025SE |
| K242091 | Bolo Button SystemHTN · Traditional | Fusion Orthopedics | 12/23/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | Vilex, LLC | 11/27/2024SE |
| K242311 | EXPERT - Flexible Joint Fixation SystemHTN · Traditional | GM Dos Reis Industria e Comercio Ltda. | 11/01/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | Vilex, LLC | 08/01/2024SE |
| K240947 | TENSOR® Suture Button SystemHTN · Traditional | Globus Medical, Inc. | 06/03/2024SE |
| K233531 | OIC FLEX-FIX SystemHTN · Traditional | Orthopaedic Implant Company | 02/02/2024SE |
| K232780 | CC-Clip® Implant SystemHTN · Traditional | Cc-Instruments, Inc. | 12/18/2023SE |
| K232755 | Arthrex FiberTape and TigerTape Cerclage SuturesHTN · Special | Arthrex, Inc. | 10/06/2023SE |
| K221485 | Arthrex FiberTape and TigerTape Cerclage SuturesHTN · Traditional | Arthrex, Inc. | 08/22/2022SE |
| K220947 | Arthrex Knotless AC Repair DevicesHTN · Traditional | Arthrex, Inc. | 06/06/2022SE |
| K220650 | TriMed Ripcord DeviceHTN · Traditional | TriMed, Inc. | 06/01/2022SE |
| K220260 | Hercules Syndesmosis Implant SystemHTN · Traditional | In2bones USA, LLC | 03/31/2022SE |
| K212990 | Acumed Ankle Syndesmosis Repair SystemHTN · Traditional | Acumed, LLC | 01/07/2022SE |
| K213644 | Arthrex Knotless Mini TightRopesHTN · Special | Arthrex, Inc. | 12/17/2021SE |
| K211612 | Medline UNITE REFLEX Dynamic DiscsHTN · Traditional | Medline Industries, Inc. | 12/10/2021SE |
| K200332 | EXPERT - Joint Fixation SystemHTN · Traditional | GM Dos Reis Industria e Comercio Ltda. | 10/29/2020SE |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemHTN · Traditional | Arthrex, Inc. | 09/03/2020SE |
| K200361 | Akros Scruture Anchor LisFranc Repair KitHTN · Traditional | Akros Medical | 04/06/2020SE |
| K190143 | LARS AC Band DeviceHTN · Traditional | Corin USA | 11/04/2019SE |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque)HTN · Traditional | Conmed Corporation | 06/28/2019SE |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent)HTN · Traditional | Conmed Corporation | 06/28/2019SE |
| K183094 | CyclaPlex Correction SystemHTN · Traditional | Cycla Orthopedics, Ltd. | 04/26/2019SE |
| K183232 | Double ENDOBUTTON Fixation DeviceHTN · Traditional | Smith and Nephew, Inc. | 03/12/2019SE |
| K180243 | Infinity-Lock Button SystemHTN · Traditional | Xiros, Ltd. | 04/03/2018SE |
| K171703 | PUMA SystemHTN · Traditional | Panther Orthopedics, Inc. | 03/01/2018SE |
| K173550 | Akros FibuLink Syndesmosis Repair KitHTN · Special | Akros Medical | 12/14/2017SE |
| K172620 | SyndesMetrics Syndesmosis Repair SystemHTN · Traditional | Mortise Medical, LLC | 11/08/2017SE |
| K170249 | GRAVITY Syndesmosis LPHTN · Traditional | Wrightmedicaltechnologyinc | 06/30/2017SE |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair KitHTN · Traditional | Smith & Nephew, Inc. | 06/08/2017SE |
| K170440 | KISSloc Suture SystemHTN · Traditional | Arthrosurface, Inc. | 05/03/2017SE |
| K162805 | Akros Fibulink Syndesmosis Repair KitHTN · Traditional | Akros Medical | 01/10/2017SE |
| K153211 | M-Fix Acromioclavicular DeviceHTN · Traditional | Coracoid Solutions, Inc. | 02/02/2016SE |
| K150359 | Tensyn PlugHTN · Traditional | Dallen Medical, Inc. | 05/07/2015SE |
| K143092 | Tensyn PlugHTN · Traditional | Dallen Medical, Inc. | 02/11/2015SE |
| K141420 | FastforwardHTN · Traditional | MedShape, Inc. | 12/18/2014SE |
| K141264 | Tensyn Band, Tensyn Fracture PlatesHTN · Traditional | Dallen Medical, Inc. | 08/21/2014SE |
| K141219 | Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsHTN · Traditional | Biomet Manufacturing Corp | 07/18/2014SE |
| K133835 | Arthrosurface Kissloc Knotless Suture SystemHTN · Traditional | Arthrosurface, Inc. | 07/03/2014SE |
| K140328 | CMC Mini TightropeHTN · Special | Arthrex, Inc. | 03/10/2014SE |
| K133858 | Tensyn BandHTN · Traditional | Dallen Medical, Inc. | 02/28/2014SE |
| K133275 | Mini TightropeHTN · Traditional | Arthrex, Inc. | 01/30/2014SE |
| K132733 | Orthohelix Syndesmosis Fixation DevicesHTN · Traditional | Orthohelix Surgical Designs, Inc. | 01/03/2014SE |
| K131850 | Tensyn BandHTN · Traditional | Dallen Medical, Inc. | 11/15/2013SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | Biopro, Inc. | 10/24/2013SE |
| K130986 | Frag-Loc SystemHTN · Traditional | Acumed, LLC | 07/23/2013SE |
| K112437 | Arthrex Fracture SystemHTN · Traditional | Arthrex, Inc. | 12/21/2011SE |
| K112111 | Acu-Sinch Repair System and Acumed Suture AnchorHTN · Traditional | Acumed, LLC | 11/14/2011SE |
| K111032 | CMC Cable FixHTN · Traditional | Instratek, Inc. | 08/31/2011SE |
| K091207 | Surgicraft Lockdown Acromioclavicular (Ac) DeviceHTN · Traditional | Surgicraft , Ltd. | 02/15/2011SE |
| K091799 | Cable Ready Cable Grip System Cable ButtonHTN · Traditional | Zimmer, Inc. | 09/11/2009SE |
| K091763 | Michelangelo Bunion System - Mabs, Model: MA6000HTN · Special | Instratek, Inc. | 08/14/2009SE |
| K090107 | Mini TightropeHTN · Traditional | Arthrex, Inc. | 08/06/2009SE |
| K082384 | Hav-Lok Bunion Correction SystemHTN · Traditional | Instratek, Inc. | 12/08/2008SE |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceHTN · Traditional | Smith & Nephew Endoscopy, Inc. | 10/21/2008SE |
| K071978 | Mini Tightrope FT Repair KitHTN · Special | Arthrex, Inc. | 08/15/2007SE |
| K061925 | Mini Tightrope Repair Kit, Model AR-8911DSHTN · Traditional | Arthrex, Inc. | 10/31/2006SE |
| K052776 | Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models AR-2257…HTN · Traditional | Arthrex, Inc. | 12/13/2005SE |
| K043145 | Bi-Cortical Bio-Post and Washer, Model AR-1367BHTN · Traditional | Arthrex, Inc. | 02/18/2005SE |
| K043411 | Resofix Bioabsorbable Expansion BoltHTN · Traditional | Resofix, Inc. | 02/17/2005SE |
| K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…HTN · Traditional | Arthrex, Inc. | 02/16/2005SE |
| K040250 | Bone-Lok HP WasherHTN · Traditional | Triage Medical, Inc. | 03/23/2004SE |
| K030619 | Odi 7.0MM Cannulated Screw SystemHTN · Traditional | Orthopedic Designs, Inc. | 04/01/2003SE |
| K023119 | Bi-Cortical Bio Post and Washer, Model AR-1367BHTN · Traditional | Arthrex, Inc. | 12/18/2002SE |
| K013806 | Synthes Metallic Spiked WashersHTN · Traditional | Synthes (Usa) | 02/08/2002SE |
| K011583 | Spiked WasherHTN · Traditional | Synthes (Usa) | 01/30/2002SE |
| K003496 | Cannulated Screw SystemHTN · Traditional | Pioneer Surgical Technology | 02/08/2001SE |
| K992617 | Hex ButtonHTN · Traditional | Pioneer Surgical Technology | 10/27/1999SE |
| K991135 | Soft Tissue Suture WasherHTN · Traditional | Depuy, Inc. | 04/29/1999SE |
| K983906 | Depuy Orthotech Spiked WasherHTN · Traditional | DePuy Orthopaedics, Inc. | 12/18/1998SE |
| K982354 | SD Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140…HTN · Traditional | Special Devices, Inc. | 11/23/1998SE |
| K983265 | Depuy Ace Composite Locking NutHTN · Traditional | Depuy Ace Medical Co. | 10/26/1998SE |
| K980944 | Synthes Schuhli Implant SystemHTN · Traditional | Synthes (Usa) | 04/27/1998SE |
| K965028 | Acumed Suture WasherHTN · Traditional | Acu Med, Inc. | 03/17/1997SE |
| K963420 | Cancellous Screw WasherHTN · Traditional | Orthopaedic Biosystems, Ltd. | 11/15/1996SE |
| K954682 | Washer, Bolt, Nut, OrthopedicHTN · Traditional | Linvatec Corp. | 02/09/1996SN |
| K954148 | Suture WasherHTN · Traditional | Acu Med, Inc. | 01/17/1996SE |
| K943782 | Bone Screw WasherHTN · Traditional | Acu Med, Inc. | 12/20/1994SE |
| K924455 | Synthes (USA) Titanium Locked Spiked WasherHTN · Traditional | Synthes (Usa) | 05/12/1993SE |
| K914472 | Spiked WasherHTN · Traditional | Synthes (Usa) | 11/07/1991SE |
| K911306 | T-Bolt and NutHTN · Traditional | Danek Medical, Inc. | 09/10/1991SE |
| K910186 | Wyman Suture WasherHTN · Traditional | Acu Med, Inc. | 07/25/1991SE |
| K910229 | Soft Tissue Suture WASHER/3 Hole WasherHTN · Traditional | Depuy, Inc. | 07/24/1991SE |
| K895107 | Ace Orthopaedic WashersHTN · Traditional | Buckman Co., Inc. | 09/11/1989SE |
| K881699 | Acromed WashersHTN · Traditional | Buckman Co., Inc. | 04/27/1988SE |
| K874669 | Ace Bone Screw NutHTN · Traditional | Buckman Co., Inc. | 12/11/1987SE |
| K843368 | Kapp Spinal ButtonHTN · Traditional | Kapp Surgical Instrument, Inc. | 09/12/1984SE |
| K834411 | Techmedica-Hewson Shoulder CleatHTN · Traditional | Techmedica, Inc. | 01/17/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1101-2023 Class II | RipCord Syndesmosis Button, REF: STA001KOverly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue… | TriMed Inc. | 12/22/2022Open, Classified |
| Z-0338-2020 Class II | cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-2918-2016 Class III | Arthrex Suture WasherThe device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in… | Arthrex, Inc. | 08/12/2016Terminated |
| Z-0394-2014 Class II | Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in…During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked… | Synthes USA HQ, Inc. | 10/03/2013Terminated |