# K203523: Fixone hybrid knotless anchor

- Pathway: 510(k) (Traditional)
- Applicant: Aju Pharm Co., Ltd.
- Decided: Dec 25, 2021 after 389 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 9 generations back to K971358 (1997). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192484: Fixone Biocomposite Anchor, Aju Pharm Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K230892: Fixone Biocomposite Anchor (2023), 0 descendants of its own

## 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 Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K203523
Methodology: https://510kreport.com/methodology