# K222423: Fixone All Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Aju Pharm Co., Ltd.
- Decided: Mar 23, 2023 after 224 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: 13 generations back to K911837 (1991). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192709: Fixone All Suture Anchor, Aju Pharm Co., Ltd. (2020) 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 non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

Source page: https://510kreport.com/device/K222423
Methodology: https://510kreport.com/methodology