# K111690: Devine Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Orthmed Medical Instrument Co., Ltd.
- Decided: Nov 22, 2011 after 159 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 K951725 (1995). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082617: Trauson General Spinal System (GSS), Trauson (Jiangsu) Medical Instrument Co., Ltd. (2009) Summary page 2.

## Most influential descendants
- K161151: Spinal fixation system (2016), 1 descendant of its own
- K172826: Cellent Spinal Systems (2018), 0 descendants of its own
- K172267: IRENE Thoracolumbar Fixation System (2018), 0 descendants of its own

## Indications for use
Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e., fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above 18.

Source page: https://510kreport.com/device/K111690
Methodology: https://510kreport.com/methodology