# K193497: Fixone Biocomposite Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Aju Pharm Co., Ltd.
- Decided: Jan 5, 2021 after 385 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 4 generations back to K915424 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032224: Biorci Screw, Smith & Nephew, Inc. (2003) Summary page 4.

## Most influential descendants
- K212912: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (2021), 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
Fixone Biocomposite Interference Screws are indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Source page: https://510kreport.com/device/K193497
Methodology: https://510kreport.com/methodology