# K210122: Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: Aug 27, 2021 after 220 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K961555 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143660: Milagro / Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2015) Summary page 5.

## Indications for use
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).

Source page: https://510kreport.com/device/K210122
Methodology: https://510kreport.com/methodology