Aju Pharm Co., Ltd.
Medical device manufacturer.
10510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233601 | Fixone Meniscal RepairMBI · Traditional | 08/02/2024SE |
| K230892 | Fixone Biocomposite AnchorMAI · Special | 06/09/2023SE |
| 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 |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1173-2026 Class II | AlternatiV+ Screw-In AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1172-2026 Class II | AlternatiV+ Max Knotless AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1171-2026 Class II | Genesis Push-In Suture AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1170-2026 Class II | Genesis Knotless AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1169-2026 Class II | Genesis Dual Thread Screw-In AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1168-2026 Class II | Genesis Screw-In AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1167-2026 Class II | Fixone Biocomposite AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |
| Z-1166-2026 Class II | Fixone Hybrid AnchorReports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and… | 12/17/2025Open, Classified |