# K082617: Trauson General Spinal System (GSS)

- Pathway: 510(k) (Traditional)
- Applicant: Trauson (Jiangsu) Medical Instrument Co., Ltd.
- Decided: Jan 15, 2009 after 128 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: 3 generations back to K951725 (1995). 7 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063601: Pilot Spinal System, Life Spine (2007) Summary page 2.

## Most influential descendants
- K111690: Devine Spinal System (2011), 3 descendants of its own
- 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
- K151458: Double Medical Universal Spine System (2016), 0 descendants of its own

## Indications for use
Trauson General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-\ql can be applied for anterior or anterolateral 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. When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (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. Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.

Source page: https://510kreport.com/device/K082617
Methodology: https://510kreport.com/methodology