# K071464: Inion Hexalon Biodegradable Acl/PCL Screw

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Aug 3, 2007 after 66 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: 4 generations back to K943806 (1995). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062466: Arthrex Interference Screw, Arthrex, Inc. (2006) Summary page 1.
- K041356: Arthrex Tenodesis Screw Family, Arthrex, Inc. (2004) Summary page 1.
- K042552: Bio-Core Interference Screw, Biomet, Inc. (2004) Summary page 1.
- K041274: Resorbable Interference Screw, Arthrotek, Inc. (2004) Summary page 1.

## Most influential descendants
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
The Inion HexalonTM Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Source page: https://510kreport.com/device/K071464
Methodology: https://510kreport.com/methodology