# K091359: Gso PCT Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Orthopaedics, LLC
- Decided: Sep 2, 2009 after 117 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: 10 generations back to K853033 (1985). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080828: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2008) Summary page 2.
- K033961: Altius Oct System, Interpore Cross Intl. (2004) Summary page 2.
- K080143: Modification to Stryker Spine Oasys System, Stryker Spine (2008) Summary page 1.
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K070966: Gso GS1 Spinal System, Gold Standard Orthopaedics, LLC (2007) Summary page 1.

## Indications for use
The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following: 1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2. Spondylolisthesis 3. Spinal stenosis 4. Fracture or dislocation 5. Revision of previous cervical or cervico-throracic spine surgery 6. Tumors The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (TI-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K091359
Methodology: https://510kreport.com/methodology