# K012027: Modification to Xia Spine System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics
- Decided: Jul 20, 2001 after 22 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K984251 (1999). 1 ancestor in all.
206 later devices descend from it; 1 cites it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984251: Xia Spine System, Howmedica, Inc. (1999) Summary page 1.

## Most influential descendants
- K013688: Modification to Xia Spinal System (2001), 205 descendants of its own
- K052181: Modification to Xia Spinal System (2005), 202 descendants of its own
- K070631: Device Modification to Radius Spinal System (2007), 201 descendants of its own
- K082608: Radius Spinal System, Vitallium Rod #486613601 (2008), 200 descendants of its own
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod (2009), 169 descendants of its own

## Indications for use
The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw fixation system, the XIA Spine System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K012027
Methodology: https://510kreport.com/methodology