# K070966: Gso GS1 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Orthopaedics, LLC
- Decided: Jul 20, 2007 after 106 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010515 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031833: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K010515: Modification to Synergy Spinal System, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K123487: Gso GS1 Cannulated Screw System (2013), 0 descendants of its own
- K091359: Gso PCT Spinal System (2009), 0 descendants of its own

## Indications for use
The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion. As a pedicle screw system, the GSO GS 1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. In addition, when used as a pedicle screw system, the GSO GS 1 Spinal System is indicated for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a posterior, non-cervical, non-pedicle screw and/pr hook fixation system, the GSO GSl Spinal System is indicated for: 1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2. Idiopathic scoliosis 3. Kyphotic deformities of the spine 4. Paralytic scoliosis and/or pelvis obliquity 5. Vertebral fracture or dislocation 6. Neuromuscular scoliosis associated with pelvic obliquity 7. Vertebral fracture or dislocation 8. Tumors 9. Spondylolisthesis 10. Stenosis 11. Pseudarthrosis 12. Unsuccessful previous attempts at spinal fusion For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GSI1 hooks and crosslinks are intended for thoracic and/or lumbar use only. In all cases, instrumentation must be at least 1 cm from any major vessel.

Source page: https://510kreport.com/device/K070966
Methodology: https://510kreport.com/methodology