Data / Medical devices / South Korea / Aju Medical Co., Ltd.

Aju Medical Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 6 510(k) clearances

Name: Aju Medical Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aju Medical Co., Ltd. is registered with the FDA (registration 3014232239) in Seongnam-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 2, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3014232239
Address: Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu, Seongnam-si Gyeonggi, South Korea, 13511
Owner or operator: AJU Medical Co., Ltd. (10056622)
Roles: Manufacturer
First device listed: December 26, 2017
Registered through: 2026
Brand names listed: AlternatiV+ Max Knotless Anchor (KPN type), AlternatiV+ Screw-In Anchor (BN type), Awl, Awl/Tapper, Drill Bit, Drill Guide, Dual Pitch Awl/Tapper, Fixone All Suture Anchor (J,JS,JM,JF type) and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 2, 2024	K233601	Fixone Meniscal Repair	MBI	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
June 9, 2023	K230892	Fixone Biocomposite Anchor	MAI	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
March 23, 2023	K222423	Fixone All Suture Anchor	MBI	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
December 25, 2021	K203523	Fixone hybrid knotless anchor	MAI	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
January 5, 2021	K193497	Fixone Biocomposite Interference Screw	HWC	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov
March 16, 2017	K162070	JOINIX CANNULAR SYSTEM	HRX	Substantially Equivalent	Aju Pharm Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 17, 2025	98312	Class II	Ongoing	Fixone Hybrid Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.	accessdata.fda.gov

Compare with other makers

Updated January 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.