Panels › Orthopedic › Product code MAI · Class 2
Fastener, Fixation, Biodegradable, Soft Tissue
Regulation 888.3030
5510(k)s in 12 months (221 all time)
9recalls in 12 months (97 all time)
96recalls that name a 510(k)
Top companies in MAI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K262357 | Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc. | MAI |
| May 28, 2026 | K253931 | Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc. | MAI |
| Mar 27, 2026 | K260294 | SF Push-in Anchor Surgical Fusion Technologies GmbH, CH | MAI |
| Feb 24, 2026 | K254055 | OSSIOfiber® Suture Anchor OSSIO , Ltd., IL | MAI |
| Feb 17, 2026 | K251680 | Biosteon® Screw Biocomposites, Ltd., GB | MAI |
| Oct 15, 2025 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit Conmed Corporation | MAI |
| Aug 19, 2025 | K252022 | OSSIOfiber® Interference Screw OSSIO , Ltd., IL | MAI |
| May 27, 2025 | K251309 | OSSIOfiber® Suture Anchor OSSIO , Ltd., IL | MAI |
| May 23, 2025 | K250544 | Knotilus+ Biocomposite Knotless Anchor Stryker Endoscopy | MAI |
| May 21, 2025 | K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor Stryker Endoscopy | MAI |
| Apr 3, 2025 | K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm OSSIO , Ltd., IL | MAI |
| Mar 14, 2025 | K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor Arthrex, Inc. | MAI |
| Feb 5, 2025 | K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor Depuy Mitek | MAI |
| Dec 3, 2024 | K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Osteonic Co., Ltd., KR | MAI |
| Sep 11, 2024 | K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors Depuy Mitek | MAI |
| Jul 29, 2024 | K241912 | BIOCHARGE Nanofiber Solutions, LLC | MAI |
| Jun 4, 2024 | K233971 | Arthrex AlloSync PushLock Suture Anchor Arthrex, Inc. | MAI |
| Apr 1, 2024 | K240288 | SF Push- in Anchor Surgical Fusion Technologies GmbH, CH | MAI |
| Mar 15, 2024 | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw Depuy Mitek | MAI |
| Mar 5, 2024 | K240090 | Argo Knotless GENESYS Anchor Conmed Corporation | MAI |
| Sep 18, 2023 | K232513 | X-Twist Biocomposite Suture Anchor Parcus Medical | MAI |
| Jul 26, 2023 | K231787 | ecoFIX® Science & Bio Materials (S.B.M.) Sas, FR | MAI |
| Jul 5, 2023 | K231641 | Rotium Bioresorbable Wick Nanofiber Solutions, LLC | MAI |
| Jun 9, 2023 | K230892 | Fixone Biocomposite Anchor Aju Pharm Co., Ltd., KR | MAI |
| May 31, 2023 | K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) Osteonic Co., Ltd., KR | MAI |
| May 12, 2023 | K230394 | EUROSCREW NG; EUROSCREW TCP NG Teknimed, FR | MAI |
| Mar 17, 2023 | K230435 | Arthrex 3.9 mm SwiveLock Anchor Arthrex, Inc. | MAI |
| Feb 14, 2023 | K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants Acuitive Technologies, Inc. | MAI |
| Nov 4, 2022 | K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL Acuitive Technologies, Inc. | MAI |
| Oct 5, 2022 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II Arthrex, Inc. | MAI |
| Aug 26, 2022 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors Arthrex, Inc. | MAI |
| May 13, 2022 | K221099 | Arthrex Self-Punching PushLock Suture Anchor Arthrex, Inc. | MAI |
| Apr 8, 2022 | K213958 | Bioabsorbable Anchor Embody, Inc. | MAI |
| Mar 28, 2022 | K213415 | OSSIOfiber Suture Anchor OSSIO , Ltd., IL | MAI |
| Dec 25, 2021 | K203523 | Fixone hybrid knotless anchor Aju Pharm Co., Ltd., KR | MAI |
| Nov 4, 2021 | K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, O B-One Ortho, Corp. | MAI |
| Aug 27, 2021 | K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) Osteonic Co., Ltd., KR | MAI |
| Jun 17, 2021 | K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Osteonic Co., Ltd., KR | MAI |
| Apr 19, 2021 | K203495 | Arthrex SwiveLock Anchor Arthrex, Inc. | MAI |
| Feb 24, 2021 | K210239 | CITRESPLINE and CITRELOCK ACL Implants Acuitive Technologies, Inc. | MAI |
| Feb 22, 2021 | K203493 | MectaLock Extension Medacta International S.A., CH | MAI |
| Feb 5, 2021 | K203334 | The Citrefix Knotless Suture Anchor Acuitive Technologies, Inc. | MAI |
| Nov 18, 2020 | K202535 | Arthrex FastThread Interference Screw Arthrex, Inc. | MAI |
| Oct 7, 2020 | K200725 | Citregen Tendon Interference Screw and Citrelock Acuitive Technologies | MAI |
| Aug 21, 2020 | K201749 | Arthrex SwiveLock Anchor Arthrex, Inc. | MAI |
| Jul 30, 2020 | K201786 | Arthrex Mini Hip PushLock Arthrex, Inc. | MAI |
| Jun 25, 2020 | K201414 | Rotium Bioresorbable Wick Nanofiber Solutions, LLC | MAI |
| Mar 18, 2020 | K193558 | HEALICOIL Knotless Suture Anchors Smith & Nephew, Inc. | MAI |
| Mar 11, 2020 | K192484 | Fixone Biocomposite Anchor Aju Pharm Co., Ltd., KR | MAI |
| Mar 3, 2020 | K192032 | Fixone Biocomposite Small Anchor Aju Pharm Co., Ltd., KR | MAI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.