# K233601: Fixone Meniscal Repair

- Pathway: 510(k) (Traditional)
- Applicant: Aju Pharm Co., Ltd.
- Decided: Aug 2, 2024 after 267 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K050021 (2005). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153667: TRUESPAN Meniscal Repair System, Medos International SARL (2016) Summary page 4.
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N, Smith & Nephew, Inc. (2012) Summary page 4.

## Recalls of this device
- Dec 17, 2025 · Class II · Z-1167-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1170-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1166-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1172-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1168-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1171-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1173-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Dec 17, 2025 · Class II · Z-1169-2026: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

## Indications for use
The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.

Source page: https://510kreport.com/device/K233601
Methodology: https://510kreport.com/methodology