# K011172: Arthrex Bio-Transfix

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 19, 2001 after 63 days
- Product code: MNU (Staple, Absorbable)
- 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K021351: Biosteon Cross Pin (2002), 1 descendant of its own
- K043106: Pinn-Acl Crosspin (2005), 0 descendants of its own
- K033792: Bilok ST Screw (2004), 0 descendants of its own
- K014305: Resorbable Lactosorb-L Acl Crosspin (2002), 0 descendants of its own

## Indications for use
The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopedic procedures.

Source page: https://510kreport.com/device/K011172
Methodology: https://510kreport.com/methodology