# K021280: Inion Hexalon Biodegradable Acl/PCL Screw

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Jul 17, 2002 after 86 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: 1 generation back to K971358 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K982497: Arthrotek Interference Screw, Biomet, Inc. (1998) Summary page 1.
- K983592: Sulzer Orthopedics Sysorb Interference Screws, Sulzer Orthopedics, Inc. (1999) Summary page 2.

## Most influential descendants
- K060393: Inion Hexalon Biodegradable Acl/PCL Screw (2006), 0 descendants of its own

## Indications for use
The Inion HexalonTM Biodegradable ACL/PCL Screw is intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.

Source page: https://510kreport.com/device/K021280
Methodology: https://510kreport.com/methodology