# K161151: Spinal fixation system

- Pathway: 510(k) (Traditional)
- Applicant: Canwell Medical Co., Ltd.
- Decided: Sep 21, 2016 after 149 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: 5 generations back to K951725 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111690: Devine Spinal System, Changzhou Orthmed Medical Instrument Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K172826: Cellent Spinal Systems (2018), 0 descendants of its own

## Indications for use
Spinal fixation 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 T8.

Source page: https://510kreport.com/device/K161151
Methodology: https://510kreport.com/methodology