Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAT — Predicate Candidate Screening
175 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
280 days90th percentile
175clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261021 | EasyWhip Family | Winter Innovations, Inc. | 2026-07-01 | 96 | 0 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026-05-06 | 57 | 0 |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 | 83 | 0 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 | 58 | 0 |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 | 27 | 0 |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025-10-16 | 27 | 0 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 | 58 | 0 |
| K252201 | HS Fiber | Riverpoint Medical | 2025-08-13 | 30 | 0 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 | 244 | 0 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 | 86 | 0 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 | 140 | 0 |
| K231163 | HS Fiber Sutures | Riverpoint Medical | 2024-01-05 | 256 | 0 |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 | 294 | 0 |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 | 121 | 0 |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023-08-10 | 262 | 0 |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 | 304 | 0 |
| K230510 | MyEllevate | Cynosure, LLC | 2023-07-06 | 132 | 0 |
| K213046 | AceConnex Pre-Sutured Fascia | Allosource | 2023-06-27 | 643 | 0 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Ten | Rti Surgical, Inc. | 2023-06-23 | 178 | 0 |
| K223822 | ACTIVBRAID™ | Embody, Inc. | 2023-06-02 | 163 | 0 |
| K220880 | Arthrex BioSuture | Arthrex, Inc. | 2022-10-27 | 216 | 0 |
| K222078 | Arthrex SoftStitch | Arthrex, Inc. | 2022-09-14 | 62 | 0 |
| K221354 | Arthrex SutureTape | Arthrex, Inc. | 2022-09-09 | 122 | 0 |
| K220186 | Zone Specific AIM | Conmed Corporation | 2022-05-13 | 109 | 0 |
| K220219 | PERMALOOP Suture, PERMATAPE Suture | Medos International SARL | 2022-04-26 | 90 | 0 |
| K212146 | Arthrex LoopLoc Knotless Suture | Arthrex, Inc. | 2021-10-25 | 108 | 0 |
| K210675 | EasyWhip | Winter Innovations, Inc. | 2021-05-03 | 59 | 0 |
| K203186 | DYNATAPE Suture | Medos International SARL | 2021-03-18 | 142 | 0 |
| K203393 | FAST-FIX FLEX | Smith & Nephew, Inc. | 2021-02-01 | 75 | 0 |
| K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020-10-02 | 563 | 0 |
| K202242 | HS Fiber | Riverpoint Medical, LLC | 2020-09-10 | 31 | 0 |
| K193575 | Arthrex SutureTape | Arthrex, Inc. | 2020-07-24 | 214 | 0 |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | Teleflex Medical | 2020-03-30 | 201 | 0 |
| K192637 | High Strength Suture | Yunyi (Beijing) Medical Device Co., Ltd. | 2020-03-02 | 160 | 0 |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | Demetech Corporation | 2019-07-31 | 127 | 0 |
| K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019-06-11 | 29 | 0 |
| K190817 | HS Fiber | Riverpoint Medical | 2019-05-01 | 30 | 0 |
| K181633 | MTF Pre-Sutured Tendon | Musculoskeletal Transplant Foundation | 2019-03-15 | 268 | 0 |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and Whi | Teleflex Medical Incorporated | 2018-10-10 | 99 | 0 |
| K181182 | DYNACORD Suture | Medos International SARL | 2018-08-02 | 91 | 0 |
| K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | Ceterix Orthopaedics, Inc. | 2018-08-01 | 29 | 0 |
| K180191 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2018-06-05 | 133 | 0 |
| K180531 | NovoStitch Pro Meniscal Repair System | Ceterix Orthopaedics, Inc. | 2018-03-29 | 29 | 0 |
| K170957 | ReConnex Pre-Sutured Tendon | Allosource | 2018-03-20 | 354 | 0 |
| K172016 | Force Fiber Fusion Suture | Teleflex Medical Incorporated | 2017-10-03 | 92 | 0 |
| K170642 | GRAVITY™ Soft Tissue Repair System | Wrightmedicaltechnologyinc | 2017-08-22 | 173 | 0 |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | Xiros, Ltd. | 2017-06-30 | 24 | 0 |
| K171296 | SutureTape | Arthrex, Inc. | 2017-05-26 | 24 | 0 |
| K163651 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2017-02-17 | 56 | 0 |
| K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, Wh | ArthroCare Corporation | 2017-01-06 | 58 | 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