Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MAI — Predicate Candidate Screening
221 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
249 days90th percentile
221clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-08-07 | 28 | 0 |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-05-28 | 170 | 0 |
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | 2026-03-27 | 57 | 0 |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2026-02-24 | 69 | 0 |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026-02-17 | 263 | 0 |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025-10-15 | 30 | 0 |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | 2025-08-19 | 50 | 0 |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2025-05-27 | 29 | 0 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | 2025-05-23 | 87 | 0 |
| K250528 | Stryker AlphaVent™ Knotless SP Biocomposite Anchor | Stryker Endoscopy | 2025-05-21 | 86 | 0 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | 2025-04-03 | 118 | 0 |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anch | Arthrex, Inc. | 2025-03-14 | 18 | 0 |
| K243790 | GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor | Depuy Mitek | 2025-02-05 | 57 | 0 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocomb | Osteonic Co., Ltd. | 2024-12-03 | 25 | 0 |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punchin | Depuy Mitek | 2024-09-11 | 152 | 0 |
| K241912 | BIOCHARGE | Nanofiber Solutions, LLC | 2024-07-29 | 28 | 0 |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. | 2024-06-04 | 172 | 0 |
| K240288 | SF Push- in Anchor | Surgical Fusion Technologies GmbH | 2024-04-01 | 60 | 0 |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Scr | Depuy Mitek | 2024-03-15 | 30 | 0 |
| K240090 | Argo Knotless GENESYS Anchor | Conmed Corporation | 2024-03-05 | 53 | 0 |
| K232513 | X-Twist Biocomposite Suture Anchor | Parcus Medical | 2023-09-18 | 31 | 0 |
| K231787 | ecoFIX® | Science & Bio Materials (S.B.M.) Sas | 2023-07-26 | 36 | 0 |
| K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2023-07-05 | 30 | 0 |
| K230892 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2023-06-09 | 70 | 8 |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punchin | Osteonic Co., Ltd. | 2023-05-31 | 23 | 0 |
| K230394 | EUROSCREW NG; EUROSCREW TCP NG | Teknimed | 2023-05-12 | 87 | 0 |
| K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex, Inc. | 2023-03-17 | 28 | 0 |
| K221468 | Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon | Acuitive Technologies, Inc. | 2023-02-14 | 270 | 0 |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Cit | Acuitive Technologies, Inc. | 2022-11-04 | 227 | 0 |
| K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. | 2022-10-05 | 170 | 0 |
| K222263 | Arthrex Self Punching SwiveLock Suture Anchors | Arthrex, Inc. | 2022-08-26 | 29 | 0 |
| K221099 | Arthrex Self-Punching PushLock Suture Anchor | Arthrex, Inc. | 2022-05-13 | 29 | 0 |
| K213958 | Bioabsorbable Anchor | Embody, Inc. | 2022-04-08 | 112 | 0 |
| K213415 | OSSIOfiber Suture Anchor | OSSIO , Ltd. | 2022-03-28 | 160 | 0 |
| K203523 | Fixone hybrid knotless anchor | Aju Pharm Co., Ltd. | 2021-12-25 | 389 | 8 |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Ancho | B-One Ortho, Corp. | 2021-11-04 | 52 | 0 |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Osteonic Co., Ltd. | 2021-08-27 | 220 | 0 |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocomb | Osteonic Co., Ltd. | 2021-06-17 | 267 | 0 |
| K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021-04-19 | 143 | 0 |
| K210239 | CITRESPLINE and CITRELOCK ACL Implants | Acuitive Technologies, Inc. | 2021-02-24 | 26 | 0 |
| K203493 | MectaLock Extension | Medacta International S.A. | 2021-02-22 | 87 | 0 |
| K203334 | The Citrefix Knotless Suture Anchor | Acuitive Technologies, Inc. | 2021-02-05 | 85 | 0 |
| K202535 | Arthrex FastThread Interference Screw | Arthrex, Inc. | 2020-11-18 | 78 | 0 |
| K200725 | Citregen Tendon Interference Screw and Citrelock | Acuitive Technologies | 2020-10-07 | 202 | 0 |
| K201749 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2020-08-21 | 56 | 0 |
| K201786 | Arthrex Mini Hip PushLock | Arthrex, Inc. | 2020-07-30 | 30 | 0 |
| K201414 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2020-06-25 | 27 | 0 |
| K193558 | HEALICOIL Knotless Suture Anchors | Smith & Nephew, Inc. | 2020-03-18 | 86 | 0 |
| K192484 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2020-03-11 | 183 | 0 |
| K192032 | Fixone Biocomposite Small Anchor | Aju Pharm Co., Ltd. | 2020-03-03 | 217 | 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