# K134011: General Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Dean Medical Instrument Co, Ltd.
- Decided: Sep 3, 2014 after 247 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). 11 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K042790: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 5.

## Indications for use
The General 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.¢. fracture or dislocation), (2) curvatures (scoliosis, kyphosts, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K134011
Methodology: https://510kreport.com/methodology