Panels › Orthopedic › Product code HTN · Class 2
Washer, Bolt Nut
Regulation 888.3030
3510(k)s in 12 months (93 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in HTN
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 16 | 1 |
| Dallen Medical, Inc. | 5 | 0 |
| Synthes (Usa) | 5 | 0 |
| Acu Med, Inc. | 4 | 0 |
| Acumed, LLC | 4 | 0 |
| Akros Medical | 3 | 0 |
| Buckman Co., Inc. | 3 | 0 |
| Instratek, Inc. | 3 | 0 |
| TriMed, Inc. | 2 | 1 |
| Arthrosurface, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2026 | K253115 | LARS ACJ Movmedix S.A.S., FR | HTN |
| Mar 27, 2026 | K252081 | SportLinc Syndesmosis Device Lincotek Medical | HTN |
| Dec 22, 2025 | K253727 | Syndesmosis TightRope PRO Arthrex, Inc. | HTN |
| Oct 29, 2025 | K251643 | Synchfix EVT Wright Medical Technology, Inc. (Stryker Corporation) | HTN |
| Jul 11, 2025 | K251134 | RipCord TriMed, Inc. | HTN |
| Jan 23, 2025 | K243624 | Acu-Sinch Knotless Mini Acumed, LLC | HTN |
| Dec 23, 2024 | K242091 | Bolo Button System Fusion Orthopedics | HTN |
| Nov 27, 2024 | K243408 | TACTIX Vector Syndesmosis System Vilex, LLC | HTN |
| Nov 1, 2024 | K242311 | EXPERT - Flexible Joint Fixation System GM Dos Reis Industria e Comercio Ltda., BR | HTN |
| Aug 1, 2024 | K240035 | TACTIX Vector Syndesmosis System Vilex, LLC | HTN |
| Jun 3, 2024 | K240947 | TENSOR® Suture Button System Globus Medical, Inc. | HTN |
| Feb 2, 2024 | K233531 | OIC FLEX-FIX System Orthopaedic Implant Company | HTN |
| Dec 18, 2023 | K232780 | CC-Clip® Implant System Cc-Instruments, Inc. | HTN |
| Oct 6, 2023 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures Arthrex, Inc. | HTN |
| Aug 22, 2022 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures Arthrex, Inc. | HTN |
| Jun 6, 2022 | K220947 | Arthrex Knotless AC Repair Devices Arthrex, Inc. | HTN |
| Jun 1, 2022 | K220650 | TriMed Ripcord Device TriMed, Inc. | HTN |
| Mar 31, 2022 | K220260 | Hercules Syndesmosis Implant System In2bones USA, LLC | HTN |
| Jan 7, 2022 | K212990 | Acumed Ankle Syndesmosis Repair System Acumed, LLC | HTN |
| Dec 17, 2021 | K213644 | Arthrex Knotless Mini TightRopes Arthrex, Inc. | HTN |
| Dec 10, 2021 | K211612 | Medline UNITE REFLEX Dynamic Discs Medline Industries, Inc. | HTN |
| Oct 29, 2020 | K200332 | EXPERT - Joint Fixation System GM Dos Reis Industria e Comercio Ltda., BR | HTN |
| Sep 3, 2020 | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Arthrex, Inc. | HTN |
| Apr 6, 2020 | K200361 | Akros Scruture Anchor LisFranc Repair Kit Akros Medical | HTN |
| Nov 4, 2019 | K190143 | LARS AC Band Device Corin USA | HTN |
| Jun 28, 2019 | K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) Conmed Corporation | HTN |
| Jun 28, 2019 | K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) Conmed Corporation | HTN |
| Apr 26, 2019 | K183094 | CyclaPlex Correction System Cycla Orthopedics, Ltd., IL | HTN |
| Mar 12, 2019 | K183232 | Double ENDOBUTTON Fixation Device Smith and Nephew, Inc. | HTN |
| Apr 3, 2018 | K180243 | Infinity-Lock Button System Xiros, Ltd., GB | HTN |
| Mar 1, 2018 | K171703 | PUMA System Panther Orthopedics, Inc. | HTN |
| Dec 14, 2017 | K173550 | Akros FibuLink Syndesmosis Repair Kit Akros Medical | HTN |
| Nov 8, 2017 | K172620 | SyndesMetrics Syndesmosis Repair System Mortise Medical, LLC | HTN |
| Jun 30, 2017 | K170249 | GRAVITY Syndesmosis LP Wrightmedicaltechnologyinc | HTN |
| Jun 8, 2017 | K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit Smith & Nephew, Inc. | HTN |
| May 3, 2017 | K170440 | KISSloc Suture System Arthrosurface, Inc. | HTN |
| Jan 10, 2017 | K162805 | Akros Fibulink Syndesmosis Repair Kit Akros Medical | HTN |
| Feb 2, 2016 | K153211 | M-Fix Acromioclavicular Device Coracoid Solutions, Inc. | HTN |
| May 7, 2015 | K150359 | Tensyn Plug Dallen Medical, Inc. | HTN |
| Feb 11, 2015 | K143092 | Tensyn Plug Dallen Medical, Inc. | HTN |
| Dec 18, 2014 | K141420 | FASTFORWARD MedShape, Inc. | HTN |
| Aug 21, 2014 | K141264 | TENSYN BAND, TENSYN FRACTURE PLATES Dallen Medical, Inc. | HTN |
| Jul 18, 2014 | K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS Biomet Manufacturing Corp | HTN |
| Jul 3, 2014 | K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM Arthrosurface, Inc. | HTN |
| Mar 10, 2014 | K140328 | CMC MINI TIGHTROPE Arthrex, Inc. | HTN |
| Feb 28, 2014 | K133858 | TENSYN BAND Dallen Medical, Inc. | HTN |
| Jan 30, 2014 | K133275 | MINI TIGHTROPE Arthrex, Inc. | HTN |
| Jan 3, 2014 | K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES Orthohelix Surgical Designs, Inc. | HTN |
| Nov 15, 2013 | K131850 | TENSYN BAND Dallen Medical, Inc. | HTN |
| Oct 24, 2013 | K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM Biopro, Inc. | HTN |
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