# K143013: Spinal Inner Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Dingjian Medical Appliance Co., Ltd.
- Decided: Dec 11, 2015 after 417 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: 3 generations back to K031655 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122994: Intramedullary Nail System, Weigao Orthopaedic Device Co., Ltd. (2013) Summary page 6.

## Most influential descendants
- K222031: Spinal Inner Fixation System (2022), 0 descendants of its own

## Indications for use
Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 — S1.

Source page: https://510kreport.com/device/K143013
Methodology: https://510kreport.com/methodology