Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Aju Pharm with 10 510(k) clearances, 8 device recalls and 1 warning letter. The most recent is a device recall dated Dec 17, 2025: AlternatiV+ Screw-In Anchor.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 17, 2025 | AlternatiV+ Screw-In AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | Genesis Push-In Suture AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | Fixone Biocomposite AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | Fixone Hybrid AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | Genesis Knotless AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | AlternatiV+ Max Knotless AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | Genesis Dual Thread Screw-In AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| Dec 17, 2025 | Genesis Screw-In AnchorClass II · Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary pa | Device recalls |
| May 21, 2025 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| Aug 2, 2024 | Fixone Meniscal RepairK233601 · MBI | 510(k) clearances |
| Jun 9, 2023 | Fixone Biocomposite AnchorK230892 · MAI | 510(k) clearances |
| Mar 23, 2023 | Fixone All Suture AnchorK222423 · MBI | 510(k) clearances |
| Dec 25, 2021 | Fixone hybrid knotless anchorK203523 · MAI | 510(k) clearances |
| Jan 5, 2021 | Fixone Biocomposite Interference ScrewK193497 · HWC | 510(k) clearances |
| Dec 15, 2020 | Fixone All Suture AnchorK192709 · MBI | 510(k) clearances |
| Mar 11, 2020 | Fixone Biocomposite AnchorK192484 · MAI | 510(k) clearances |
| Mar 3, 2020 | Fixone Biocomposite Small AnchorK192032 · MAI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
