Product code MAI
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-08-07 |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026-05-28 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888867627864 | Arthrex® | ARTHREX, INC. | 2026-10-07 |
| 00888867627857 | Arthrex® | ARTHREX, INC. | 2026-10-07 |
| 00888867627840 | Arthrex® | ARTHREX, INC. | 2026-10-07 |
| 07613327662054 | ALPHAVENT | STRYKER CORPORATION | 2025-06-16 |
| 07613327662047 | ALPHAVENT | STRYKER CORPORATION | 2025-06-16 |
| 07613327662030 | ALPHAVENT | STRYKER CORPORATION | 2025-06-16 |
| 00840277405029 | OC JuggerKnotless® Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405081 | OC JuggerLoop™ Soft Anchor SP | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405074 | OC JuggerLoop™ Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405067 | OC JuggerLoop™ Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405050 | OC JuggerLoop™ Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405043 | OC JuggerKnotless® Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405036 | OC JuggerKnotless® Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00840277405012 | OC JuggerKnotless® Soft Anchor | RIVERPOINT MEDICAL, LLC | 2024-12-19 |
| 00888867429857 | Arthrex® | ARTHREX, INC. | 2023-05-24 |
| 00888867429864 | Arthrex® | ARTHREX, INC. | 2023-05-24 |
| 00888867429871 | Arthrex® | ARTHREX, INC. | 2023-05-24 |
| 00888867429888 | Arthrex® | ARTHREX, INC. | 2023-05-24 |
| 00888867354067 | Arthrex® | ARTHREX, INC. | 2020-12-15 |
| 10886705002085 | BIOKNOTLESS ORTHOCORD ETHIBOND | Medos International Sàrl | 2015-09-01 |
| 10886705002122 | BIOKNOTLESS ORTHOCORD ETHIBOND | Medos International Sàrl | 2015-09-01 |
| 10886705002399 | QUICKANCHOR ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705002405 | QUICKANCHOR ETHIBOND TAPERCUT | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705002443 | MICROFIX QUICKANCHOR ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705002450 | MICROFIX QUICKANCHOR ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705002467 | MICROFIX QUICKANCHOR ETHIBOND | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705007530 | HEALIX PEEK ORTHOCORD | Medos International Sàrl | 2015-09-01 |
| 10886705007554 | HEALIX PEEK ORTHOCORD | Medos International Sàrl | 2015-09-01 |
| 10886705007578 | HEALIX PEEK ORTHOCORD | Medos International Sàrl | 2015-09-01 |
| 10886705007585 | HEALIX PEEK ORTHOCORD | Medos International Sàrl | 2015-09-01 |