# K990721: Isolock Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Scien'Tx USA, Inc.
- Decided: May 27, 1999 after 83 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: 1 generation back to K951846 (1996). 2 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951846: Mirage Spinal System for Severe Spondylolisthesis, Alphatec Mfg., Inc. (1996) Summary page 1.
- K984350: VSP System, Depuy Motech Acromed (1999) Summary page 1.

## Most influential descendants
- K001080: Spine System Evolution (2000), 62 descendants of its own
- K112551: S4 Spinal System (2011), 61 descendants of its own
- K123352: S4 Spinal System (2012), 51 descendants of its own
- K130291: S4 Spinal System (2013), 44 descendants of its own
- K182377: CarboClear® Pedicle Screw System (2018), 39 descendants of its own

## Indications for use
The ISOLOCK 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the ISOLOCK 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/K990721
Methodology: https://510kreport.com/methodology