# K990118: Isobar Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Scien'Tx USA, Inc.
- Decided: Mar 22, 1999 after 68 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 K901587 (1990). 25 ancestors in all.
250 later devices descend from it; 14 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980484: Aesculap Spine System Evolution, Aesculap, Inc. (1998) Summary page 1.
- K982914: Aesculap Spine System Evolution: Additional Components, Aesculap, Inc. (1998) Summary page 1.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 1.
- K951846: Mirage Spinal System for Severe Spondylolisthesis, Alphatec Mfg., Inc. (1996) Summary page 1.

## Most influential descendants
- K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020 (2006), 131 descendants of its own
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body (2010), 117 descendants of its own
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), 116 descendants of its own
- K013444: Isobar Spinal System (2001), 94 descendants of its own

## Indications for use
The ISOBAR Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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.

Source page: https://510kreport.com/device/K990118
Methodology: https://510kreport.com/methodology