# K991326: Isobar Semi-Rigid Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Scien'Tx USA, Inc.
- Decided: Nov 8, 1999 after 203 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: 5 generations back to K901587 (1990). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.

## Most influential descendants
- K073143: Modified Vertiflex Spinal Screw System (2008), 0 descendants of its own
- K042953: Modification to Protex Stabilization System (2004), 0 descendants of its own

## Indications for use
The ISOBAR Semi-rigid 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the ISOBAR Semi-rigid Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

Source page: https://510kreport.com/device/K991326
Methodology: https://510kreport.com/methodology