# K103070: GPS TM, G Surgical Anterior Cervical Plate System +

- Pathway: 510(k) (Traditional)
- Applicant: G Surgical Co., Ltd.
- Decided: Jan 12, 2011 after 86 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- 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: 1 generation back to K000536 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 1.

## Indications for use
The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of the discogenic origin with degeneration of disc confirmed by patient history and radiographic studies) * Trauma (including fractures) * Tumors * Deformities or curvatures (including kyphosis, lordosis, or scoliosis) * Pseudarthrosis * Failed previous fusion * Spondylolisthesis * Spinal Stenosis Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K103070
Methodology: https://510kreport.com/methodology