# K110990: Gso ACP1 Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Orthopedics, LLC
- Decided: Jul 25, 2011 after 108 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: 2 generations back to K002592 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 2.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 2.
- K974885: Blackstone Medical Inc. Anterior Cervical Plate System, Blackstone Medical, Inc. (1998) Summary page 2.
- K040844: Life Spine Neo Anterior Cervical Plate System, Life Spine, LLC (2004) Summary page 2.
- K060025: Slimplicity Anterior Cervical Plate System, Spinal USA (2006) Summary page 2.
- K023133: Modification to Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2002) Summary page 2.

## Indications for use
The GSO ACPI Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, deformity (defined as kyphosis, lordlosis, or scoliosis), pseudlarthroses, and/or failed previous fusions. WARNING: This device system is intended for anterior cervical interbody fusions only. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K110990
Methodology: https://510kreport.com/methodology