# K092360: ACP4 Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Jan 22, 2010 after 171 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The X-Spine ACP4 System is intended for anterior screw fixation to the cervical spine (C2-C7 inclusive). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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 (i.e., fractures or dislocations), * Tumo~rs, * Deformity (defined as kyphosis, lordlosis, or scoli~osis) * Pseudloarthrosis, and/or * Failed previous-fusions.

Source page: https://510kreport.com/device/K092360
Methodology: https://510kreport.com/methodology