# K031290: Modification to Easys Transverse Connection

- Pathway: 510(k) (Special)
- Applicant: Scient'X USA, Inc.
- Decided: May 13, 2003 after 20 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nonpedicle screw fixation of the noncervical spinehook and sacraliliac screw fixation to the noncervical spinehook and sacral screw fixation to the T1-S1 spine. Indications for use include: degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis trauma (i.e., fracture or dislocation) spinal stenosis deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) tumor pseudoarthrosis failed previous fusion The ISOBAR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 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. The ISOBAR Spinal System is a pedicle screw system 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/K031290
Methodology: https://510kreport.com/methodology