# K113324: Rexious Hook Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Co., Ltd.
- Decided: Mar 28, 2012 after 139 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- 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: 3 generations back to K884263 (1988). 9 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031595: U & I America Spinal Hook System, U&I Corp., America (2003) Summary page 2.

## Most influential descendants
- K132365: Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation (2013), 2 descendants of its own
- K222415: Rexious Spinal Fixation System (2022), 1 descendant of its own
- K140219: Picasso II Mis Spinal System (2014), 1 descendant of its own
- K232586: Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System (2023), 0 descendants of its own
- K173185: SEURAT™ Universal Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
The Rexious Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Rexious Hook System can be used in conjunction with the Rexious Spinal Fixation System.

Source page: https://510kreport.com/device/K113324
Methodology: https://510kreport.com/methodology