Fixone Biocomposite Anchor
FDA 510(k) K230892 · Aju Pharm Co., Ltd.
510(k) numberK230892
Submission
- Device name
- Fixone Biocomposite Anchor
- Applicant
- Aju Pharm Co., Ltd.
Seongnam-Si, KR - Received
- March 31, 2023
- Decision date
- June 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
More from Stryker Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K233601 | Fixone Meniscal RepairMBI · Traditional | 08/02/2024SE |
| K222423 | Fixone All Suture AnchorMBI · Special | 03/23/2023SE |
| K203523 | Fixone hybrid knotless anchorMAI · Traditional | 12/25/2021SE |
| K193497 | Fixone Biocomposite Interference ScrewHWC · Traditional | 01/05/2021SE |
| K192709 | Fixone All Suture AnchorMBI · Traditional | 12/15/2020SE |
| K192484 | Fixone Biocomposite AnchorMAI · Special | 03/11/2020SE |
| K192032 | Fixone Biocomposite Small AnchorMAI · Traditional | 03/03/2020SE |
| K171299 | Fixone Biocomposite AnchorMAI · Traditional | 08/24/2017SE |
| K162070 | Joinix Cannular SystemHRX · Traditional | 03/16/2017SE |
Questions and answers
When was Fixone Biocomposite Anchor cleared by the FDA?
Fixone Biocomposite Anchor (K230892) received a 510(k) decision of Substantially Equivalent on June 9, 2023, 70 days after the submission was received.
What is the product code of K230892?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.