# K031939: Bio-Eurolig Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Jun 24, 2004 after 367 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 3 generations back to K915424 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992396: Biorci Screw, Smith & Nephew Endoscopy, Inc. (2000) Summary page 1.
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 1.
- K971358: Bio-Interference Screw, 7 MM, 8 MM, 9 MM, Arthrex, Inc. (1997) Summary page 1.

## Indications for use
The B10-EUROLIG® screw is intended to provide interference fixations of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.

Source page: https://510kreport.com/device/K031939
Methodology: https://510kreport.com/methodology