# K202883: Sterile bone screw (PEEK ACL screw)

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: Nov 25, 2020 after 58 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 5.

## Indications for use
The Sterile bone screw (PEEK 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. Knee • ACL repairs • PCL repairs • Extra-capsular repairs – Medial collateral ligament – Lateral collateral ligament – Posterior oblique ligament • Patellar realignment and tendon repairs – Vastus medialis obliquus advancement • Iliotibial band tenodesis

Source page: https://510kreport.com/device/K202883
Methodology: https://510kreport.com/methodology