Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTN — Predicate Candidate Screening
93 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
210 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253115 | LARS ACJ | Movmedix S.A.S. | 2026-06-10 | 259 | 0 |
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical | 2026-03-27 | 268 | 0 |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 2025-12-22 | 28 | 0 |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 | 153 | 0 |
| K251134 | RipCord | TriMed, Inc. | 2025-07-11 | 91 | 0 |
| K243624 | Acu-Sinch Knotless Mini | Acumed, LLC | 2025-01-23 | 59 | 0 |
| K242091 | Bolo Button System | Fusion Orthopedics | 2024-12-23 | 159 | 0 |
| K243408 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-11-27 | 26 | 0 |
| K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 | 88 | 0 |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | 2024-08-01 | 210 | 0 |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | 2024-06-03 | 56 | 0 |
| K233531 | OIC FLEX-FIX™ System | Orthopaedic Implant Company | 2024-02-02 | 92 | 0 |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | 2023-12-18 | 98 | 0 |
| K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023-10-06 | 28 | 0 |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022-08-22 | 91 | 0 |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | 2022-06-06 | 66 | 0 |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | 2022-06-01 | 86 | 1 |
| K220260 | Hercules Syndesmosis Implant System | In2bones USA, LLC | 2022-03-31 | 59 | 0 |
| K212990 | Acumed Ankle Syndesmosis Repair System | Acumed, LLC | 2022-01-07 | 109 | 0 |
| K213644 | Arthrex Knotless Mini TightRopes | Arthrex, Inc. | 2021-12-17 | 29 | 0 |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | 2021-12-10 | 198 | 0 |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020-10-29 | 262 | 0 |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant Syst | Arthrex, Inc. | 2020-09-03 | 87 | 0 |
| K200361 | Akros Scruture Anchor LisFranc Repair Kit | Akros Medical | 2020-04-06 | 52 | 0 |
| K190143 | LARS AC Band Device | Corin USA | 2019-11-04 | 279 | 0 |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | Conmed Corporation | 2019-06-28 | 114 | 0 |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | Conmed Corporation | 2019-06-28 | 116 | 0 |
| K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | 2019-04-26 | 170 | 0 |
| K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019-03-12 | 112 | 0 |
| K180243 | Infinity-Lock Button System | Xiros, Ltd. | 2018-04-03 | 64 | 0 |
| K171703 | PUMA System | Panther Orthopedics, Inc. | 2018-03-01 | 266 | 0 |
| K173550 | Akros FibuLink™ Syndesmosis Repair Kit | Akros Medical | 2017-12-14 | 28 | 0 |
| K172620 | SyndesMetrics Syndesmosis Repair System | Mortise Medical, LLC | 2017-11-08 | 69 | 0 |
| K170249 | GRAVITY™ Syndesmosis LP | Wrightmedicaltechnologyinc | 2017-06-30 | 154 | 0 |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Smith & Nephew, Inc. | 2017-06-08 | 224 | 0 |
| K170440 | KISSloc Suture System | Arthrosurface, Inc. | 2017-05-03 | 78 | 0 |
| K162805 | Akros Fibulink Syndesmosis Repair Kit | Akros Medical | 2017-01-10 | 97 | 0 |
| K153211 | M-Fix Acromioclavicular Device | Coracoid Solutions, Inc. | 2016-02-02 | 89 | 0 |
| K150359 | Tensyn Plug | Dallen Medical, Inc. | 2015-05-07 | 84 | 0 |
| K143092 | Tensyn Plug | Dallen Medical, Inc. | 2015-02-11 | 106 | 0 |
| K141420 | FASTFORWARD | MedShape, Inc. | 2014-12-18 | 203 | 0 |
| K141264 | TENSYN BAND, TENSYN FRACTURE PLATES | Dallen Medical, Inc. | 2014-08-21 | 98 | 0 |
| K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPL | Biomet Manufacturing Corp | 2014-07-18 | 67 | 0 |
| K133835 | ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM | Arthrosurface, Inc. | 2014-07-03 | 197 | 0 |
| K140328 | CMC MINI TIGHTROPE | Arthrex, Inc. | 2014-03-10 | 28 | 0 |
| K133858 | TENSYN BAND | Dallen Medical, Inc. | 2014-02-28 | 71 | 0 |
| K133275 | MINI TIGHTROPE | Arthrex, Inc. | 2014-01-30 | 98 | 0 |
| K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | Orthohelix Surgical Designs, Inc. | 2014-01-03 | 122 | 0 |
| K131850 | TENSYN BAND | Dallen Medical, Inc. | 2013-11-15 | 147 | 0 |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | Biopro, Inc. | 2013-10-24 | 73 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda