# K060393: Inion Hexalon Biodegradable Acl/PCL Screw

- Pathway: 510(k) (Special)
- Applicant: Inion, Ltd.
- Decided: Mar 13, 2006 after 26 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: 2 generations back to K971358 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021280: Inion Hexalon Biodegradable Acl/PCL Screw, Inion, Ltd. (2002) Summary page 1.

## Indications for use
The INION HEXALON TM BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.

Source page: https://510kreport.com/device/K060393
Methodology: https://510kreport.com/methodology