# K152132: X-spine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Sep 25, 2015 after 56 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K950697 (1995). 75 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122145: Lanx Spinal Fixation System, Lanx, Inc. (2012) Summary page 4.
- K090224: Fortex Pedicle Screw System, X-Spine Systems, Inc. (2009) Summary page 4.
- K120832: Fortex Pedicle Screw System, X-Spine Systems, Inc. (2012) Summary page 4.

## Most influential descendants
- K180153: X-spine Cortical Bone Screw System (2018), 0 descendants of its own

## Recalls of this device
- Feb 18, 2026 · Class II · Z-1773-2026: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

## Indications for use
The X-spine℠ Pedicle Screw System is 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 X-spine℠ Pedicle Screw System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal fixation 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/K152132
Methodology: https://510kreport.com/methodology