# K071274: Gso GS1 Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Orthopedics, LLC
- Decided: Aug 24, 2007 after 109 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K841189 (1984). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043349: Open Radiotransparent Intersomatic Implant (Roi), Ldr Spine USA (2005) Summary page 1.
- K042268: Ebi Cas Spine Spacer System, Ebi, L.P. (2004) Summary page 1.

## Indications for use
The GSO GSI Spacer is intended for use in the thoracolunibar spine (i~e.TI - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The 051' Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of Pine. Supplemental internal fixation is requfired to properly utilize this system.

Source page: https://510kreport.com/device/K071274
Methodology: https://510kreport.com/methodology