Aju Medical Co., Ltd.

Seongnam-si Gyeonggi, KR

Aju Medical Co., Ltd. appears in FDA device records in Seongnam-si Gyeonggi, KR. FDA records list 10 510(k) clearances between 2017-03-16 and 2024-08-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 8 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 8
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Aju Medical Co., Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Aju Pharm Co., Ltd.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 10 510(k) clearances for Aju Medical Co., Ltd. between 2017 and 2024. The busiest year on record is 2020, with 3. The most recent is 2024, with 1.

Clearances by year, as a table

510(k) clearance decisions for Aju Medical Co., Ltd., by decision year
Year	Clearances
2017	2
2020	3
2021	2
2023	2
2024	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K233601	Fixone Meniscal Repair	MBI	Substantially Equivalent	2024-08-02
K230892	Fixone Biocomposite Anchor	MAI	Substantially Equivalent	2023-06-09
K222423	Fixone All Suture Anchor	MBI	Substantially Equivalent	2023-03-23
K203523	Fixone hybrid knotless anchor	MAI	Substantially Equivalent	2021-12-25
K193497	Fixone Biocomposite Interference Screw	HWC	Substantially Equivalent	2021-01-05
K192709	Fixone All Suture Anchor	MBI	Substantially Equivalent	2020-12-15
K192484	Fixone Biocomposite Anchor	MAI	Substantially Equivalent	2020-03-11
K192032	Fixone Biocomposite Small Anchor	MAI	Substantially Equivalent	2020-03-03
K171299	Fixone Biocomposite Anchor	MAI	Substantially Equivalent	2017-08-24
K162070	JOINIX CANNULAR SYSTEM	HRX	Substantially Equivalent	2017-03-16

Registered establishments

FDA registered establishments for Aju Medical Co., Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3014232239	3014232239	Aju Medical Co., Ltd.	Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu, Seongnam-si Gyeonggi 13511 KR	2026	HRX HWC LXH MAI MBI

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
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.	Class II	2025-12-17	Open, Classified
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.	Class II	2025-12-17	Open, Classified
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.	Class II	2025-12-17	Open, Classified
Z-1170-2026	Genesis Knotless Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	Class II	2025-12-17	Open, Classified
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.	Class II	2025-12-17	Open, Classified
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.	Class II	2025-12-17	Open, Classified
Z-1167-2026	Fixone Biocomposite Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	Class II	2025-12-17	Open, Classified
Z-1166-2026	Fixone Hybrid Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	Class II	2025-12-17	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain