# K223790: Huvex Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Corp.
- Decided: Mar 9, 2023 after 80 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K162849 (2017). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162849: Huvex Interspinous Fixation System, Dio Medical Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System (2023), 1 descendant of its own
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own

## Indications for use
The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

Source page: https://510kreport.com/device/K223790
Methodology: https://510kreport.com/methodology