# K992792: Xia Spinal System C-C Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 16, 1999 after 89 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
63 later devices descend from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Xia™ Spinal System L-Connector: named in the summary without a submission number

## Most influential descendants
- K001080: Spine System Evolution (2000), 62 descendants of its own
- K112551: S4 Spinal System (2011), 61 descendants of its own
- K123352: S4 Spinal System (2012), 51 descendants of its own
- K130291: S4 Spinal System (2013), 44 descendants of its own
- K182377: CarboClear® Pedicle Screw System (2018), 39 descendants of its own

## Indications for use
The subject components, Howmedica Osteonics® Xia™ Spinal System C-C Adaptor, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Howmedica Osteonics® Xia™ Spinal System. 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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium. 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (psuedoarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal System is indicated for patients with degenerative disc disease of the thoracic, lumbar, 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, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.

Source page: https://510kreport.com/device/K992792
Methodology: https://510kreport.com/methodology