# K162849: Huvex Interspinous Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Co., Ltd.
- Decided: Feb 16, 2017 after 128 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
No predicates in its family tree.
3 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)
- None. The summary cites 6 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K131238: Affix Spinous Process Plate System, Nuvasive, Inc. (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K143388: Affix IIS Spinous Process Plate System, Nu Vasive, Incorporated (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K103205: Bridgepoint  Spinous Process Camp- Posterior Fixation System, Alphatec Spine, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K140236: Aileron Interspinous Fixation System, Life Spine, Inc. (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K223790: Huvex Interspinous Fusion System (2023), 2 descendants of its own
- 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 Fixation System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the spinous processes 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 Fixation 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/K162849
Methodology: https://510kreport.com/methodology