# K020245: Modification to Isobar Spinal System

- Pathway: 510(k) (Special)
- Applicant: Scien'Tx USA, Inc.
- Decided: Feb 1, 2002 after 8 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: 5 generations back to K901587 (1990). 26 ancestors in all.
43 later devices descend from it; 3 cite it directly.
0 of 70 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
- K042964: MX Monoaxial Pedicle Screw (2004), 38 descendants of its own
- K043001: MX Polyaxial Pedicle Screw (2004), 37 descendants of its own
- K062912: Scient'x Spinal System (2007), 36 descendants of its own
- K133369: Tiger Spine System (2014), 29 descendants of its own
- K153453: Inertia Pedicle Screw and Deformity Correxxion System (2016), 17 descendants of its own

## Indications for use
The ISOBAR Closed Pedicle Screw is to be used in conjunction with the ISOBAR Spinal System, 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the ISOBAR 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. When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

Source page: https://510kreport.com/device/K020245
Methodology: https://510kreport.com/methodology