# K123487: Gso GS1 Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Orthopaedics, LLC
- Decided: Mar 11, 2013 after 118 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: 14 generations back to K853033 (1985). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070966: Gso GS1 Spinal System, Gold Standard Orthopaedics, LLC (2007) Summary page 3.
- K121020: Viper System, Depuy Spine, Inc. (2012) Summary page 1.
- K032265: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.

## Indications for use
The GSO OSI Cannulated Screw 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 GSI Cannulated Screw System should be removed after fusion. As a pedicle screw system, the GSO GSI Cannulated Screw 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 (133 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 GSI Cannulated Screw 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 tumnor, and failed previous fusion (pseudartlirosis). When used as a posterior, non-cervical, non-pedicle screw and/or book fixation system, the GSO GSI Cannulated Screw 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 GSI screws are intended for sacral/iliac attachment only and the GSO GSI hooks and crosslinks are intended for thoracic and/or lumbar use only.

Source page: https://510kreport.com/device/K123487
Methodology: https://510kreport.com/methodology