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 |
|---|---|---|---|
| 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 |
| K222263 | Arthrex Self Punching SwiveLock Suture Anchors | Arthrex, Inc. | 2022-08-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816537023029 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00816537023012 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00816537023234 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00816537023067 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00816537023043 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00816537023036 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00816537023050 | FiberFIX | NANOVA BIO MATERIALS INC | 2026-06-09 |
| 00888867291829 | Arthrex® | ARTHREX, INC. | 2019-03-15 |
| 00888867098169 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867013742 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867204645 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867026940 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 07613327096071 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327096033 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327096019 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095470 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095463 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095418 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327095371 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613252495116 | SONICFUSION | Stryker GmbH | 2016-09-24 |
| 07613327096088 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096095 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096125 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096149 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613327096156 | SonicAnchor | Stryker GmbH | 2015-09-24 |
| 07613252727002 | DELTA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613154470891 | Biozip | STRYKER CORPORATION | 2015-09-09 |
| 07613154019861 | Biozip | STRYKER CORPORATION | 2015-09-09 |
| 07613154092604 | Xcel | STRYKER CORPORATION | 2015-09-08 |
| 07613154567249 | Xcel | STRYKER CORPORATION | 2015-09-04 |