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Aju Pharm Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
10
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1167-2026Class IIFixone Biocomposite AnchorDecember 17, 2025
Z-1173-2026Class IIAlternatiV+ Screw-In AnchorDecember 17, 2025
Z-1168-2026Class IIGenesis Screw-In AnchorDecember 17, 2025
Z-1170-2026Class IIGenesis Knotless AnchorDecember 17, 2025
Z-1172-2026Class IIAlternatiV+ Max Knotless AnchorDecember 17, 2025
Z-1169-2026Class IIGenesis Dual Thread Screw-In AnchorDecember 17, 2025
Z-1166-2026Class IIFixone Hybrid AnchorDecember 17, 2025
Z-1171-2026Class IIGenesis Push-In Suture AnchorDecember 17, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K233601Fixone Meniscal RepairAugust 2, 2024
K230892Fixone Biocomposite AnchorJune 9, 2023
K222423Fixone All Suture AnchorMarch 23, 2023
K203523Fixone hybrid knotless anchorDecember 25, 2021
K193497Fixone Biocomposite Interference ScrewJanuary 5, 2021
K192709Fixone All Suture AnchorDecember 15, 2020
K192484Fixone Biocomposite AnchorMarch 11, 2020
K192032Fixone Biocomposite Small AnchorMarch 3, 2020
K171299Fixone Biocomposite AnchorAugust 24, 2017
K162070JOINIX CANNULAR SYSTEMMarch 16, 2017