# K062912: Scient'x Spinal System

- Pathway: 510(k) (Special)
- Applicant: Scient'X
- Decided: Feb 5, 2007 after 131 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: 7 generations back to K901587 (1990). 45 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051063: Polyaxial Hemispherical Spinal Screws, Scient'X (2005) Summary page 1.
- K013444: Isobar Spinal System, Scien'Tx USA, Inc. (2001) Summary page 1.
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.
- K043001: MX Polyaxial Pedicle Screw, Scient'X (2004) Summary page 1.
- K042964: MX Monoaxial Pedicle Screw, Scient'X (2004) Summary page 1.
- K062785: LTD Polyaxial Fixation System, Us Spine (2006). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K133369: Tiger Spine System (2014), 29 descendants of its own
- K153453: Inertia Pedicle Screw and Deformity Correxxion System (2016), 17 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle 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, * Kyphosis, * Spinal tumor, and * Failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K062912
Methodology: https://510kreport.com/methodology