Product code MAI
Current FDA Classification
- Device name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | 2026-03-27 |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2026-02-24 |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026-02-17 |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025-10-15 |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | 2025-08-19 |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | 2025-05-27 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | 2025-05-23 |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy | 2025-05-21 |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. | 2025-04-03 |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex, Inc. | 2025-03-14 |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | Depuy Mitek | 2025-02-05 |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2024-12-03 |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek | 2024-09-11 |
| K241912 | BIOCHARGE | Nanofiber Solutions, LLC | 2024-07-29 |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex, Inc. | 2024-06-04 |
| K240288 | SF Push- in Anchor | Surgical Fusion Technologies GmbH | 2024-04-01 |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | 2024-03-15 |
| K240090 | Argo Knotless GENESYS Anchor | Conmed Corporation | 2024-03-05 |
| K232513 | X-Twist Biocomposite Suture Anchor | Parcus Medical | 2023-09-18 |
| K231787 | ecoFIX® | Science & Bio Materials (S.B.M.) Sas | 2023-07-26 |
| K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2023-07-05 |
| K230892 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2023-06-09 |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2023-05-31 |
| K230394 | EUROSCREW NG; EUROSCREW TCP NG | Teknimed | 2023-05-12 |
| K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex, Inc. | 2023-03-17 |
| K221468 | Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants | Acuitive Technologies, Inc. | 2023-02-14 |
| K220833 | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL | Acuitive Technologies, Inc. | 2022-11-04 |
| K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Arthrex, Inc. | 2022-10-05 |
| K222263 | Arthrex Self Punching SwiveLock Suture Anchors | Arthrex, Inc. | 2022-08-26 |
| K221099 | Arthrex Self-Punching PushLock Suture Anchor | Arthrex, Inc. | 2022-05-13 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888867561700 | Arthrex® | ARTHREX, INC. | 2026-03-17 |
| 00888867561694 | Arthrex® | ARTHREX, INC. | 2026-03-17 |
| 00888867561687 | Arthrex® | ARTHREX, INC. | 2026-03-17 |
| 06438394007550 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007543 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007536 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007529 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007505 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007499 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007444 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007420 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007413 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007406 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 06438394007376 | ActivaScrew™ Interference | Bioretec Oy | 2026-02-05 |
| 10886705029884 | GRYPHON DYNACORD | Medos International Sàrl | 2018-09-04 |
| 10886705029877 | GRYPHON DYNACORD | Medos International Sàrl | 2018-09-04 |
| 10886705029532 | HEALIX ADVANCE BR ANCHOR w/DYNACORD | Medos International Sàrl | 2018-04-16 |
| 10886705029525 | HEALIX ADVANCE BR ANCHOR w/DYNACORD | Medos International Sàrl | 2018-04-16 |
| 10886705029518 | HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD | Medos International Sàrl | 2018-04-16 |
| 10886705029464 | HEALIX ADVANCE BR ANCHOR w/DYNACORD | Medos International Sàrl | 2018-04-16 |
| 10886705029457 | HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD | Medos International Sàrl | 2018-04-16 |
| 10886705029402 | HEALIX ADVANCE BR ANCHOR w/DYNACORD | Medos International Sàrl | 2018-04-16 |
| 10886705026661 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026753 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026746 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026739 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026722 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026715 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026685 | INTRAFIX | Medos International Sàrl | 2017-01-18 |
| 10886705026678 | INTRAFIX | Medos International Sàrl | 2017-01-18 |