# K053115: Xia Spinal System

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Dec 6, 2005 after 29 days
- Product code: MNI (Orthosis, Spinal Pedicle 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 K962628 (1997). 4 ancestors in all.
889 later devices descend from it; 4 cite it directly.
1 of 894 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K031090: Modification to Xia Stainless Steel System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 1.

## Most influential descendants
- K060361: Xia Spinal System, Xia 4.5 Spinal System (2006), 734 descendants of its own
- K060979: Xia Titanium and 4.5 Spinal Systems (2006), 710 descendants of its own
- K061202: Revere Stabilization System (2006), 547 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- K090230: Expedium Spine System (2009), 462 descendants of its own

## Indications for use
The Xia® Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia ® Spinal 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 ® Spinal 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 as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia® Spinal 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. The 6mm diameter rods from the DIAPASON' TM Spinal System and OPUS Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia ® Titanium Spinal System.

Source page: https://510kreport.com/device/K053115
Methodology: https://510kreport.com/methodology