Chrysalis Intelligence · Sponsors · Aju Pharm Co., Ltd.

Aju Pharm Co., Ltd.

Seongnam-Si, KR · 8 510(k) clearances · 8 recalls

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Total clearances
8
2020-03-03 → 2024-08-02
Last 12 months
0
Product codes
3
Most recent
2024-08-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MAI Fastener, Fixation, Biodegradable, Soft Tissue Class II Orthopedic 4 2023-06-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 3 2024-08-02
HWC Screw, Fixation, Bone Class II Orthopedic 1 2021-01-05
Safety

Recalls (8)

Class I (serious)
0
Risk of injury / death
Total recalls
8
Currently ongoing
8
Most recent
2025-12-17
DateSeverityStatusRecall # ProductCodeReason
2025-12-17 Class II Ongoing Z-1173-2026 AlternatiV+ Screw-In Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1172-2026 AlternatiV+ Max Knotless Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1171-2026 Genesis Push-In Suture Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1170-2026 Genesis Knotless Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1169-2026 Genesis Dual Thread Screw-In Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1168-2026 Genesis Screw-In Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1167-2026 Fixone Biocomposite Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17 Class II Ongoing Z-1166-2026 Fixone Hybrid Anchor — Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2024-08-02 K233601 Fixone Meniscal Repair MBI Class II Orthopedic
2023-06-09 K230892 Fixone Biocomposite Anchor MAI Class II Orthopedic
2023-03-23 K222423 Fixone All Suture Anchor MBI Class II Orthopedic
2021-12-25 K203523 Fixone hybrid knotless anchor MAI Class II Orthopedic
2021-01-05 K193497 Fixone Biocomposite Interference Screw HWC Class II Orthopedic
2020-12-15 K192709 Fixone All Suture Anchor MBI Class II Orthopedic
2020-03-11 K192484 Fixone Biocomposite Anchor MAI Class II Orthopedic
2020-03-03 K192032 Fixone Biocomposite Small Anchor MAI Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence