# K111995: Xingtm Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Implanova Co., Ltd.
- Decided: Dec 12, 2011 after 152 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: 4 generations back to K000319 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001668: Global Spinal Fixation System, D.K.M. Co., Ltd. (2000) Summary page 3.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K060702: 4CIS Vane Spine System, Solco Biomedical Co., Ltd. (2006) Summary page 2.
- K041808: Endius Title 2 Polyaxial Spinal System, Endius, Inc. (2004) Summary page 2.
- K071857: Delta Spinal Fusion System, Jemo Spine, LLC (2007) Summary page 2.

## Indications for use
The XingTM Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the XingTM Spine System is 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 (pseudarthrosis).

Source page: https://510kreport.com/device/K111995
Methodology: https://510kreport.com/methodology