# K041469: Anterior Compact System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems
- Decided: Jul 30, 2004 after 58 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.
53 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes CSLP System: named in the summary without a submission number

## Most influential descendants
- K100265: Diamond Anterior Cervical Plate System (2010), 34 descendants of its own
- K113329: K2M, Pyrenees Cervical Plate System (2012), 28 descendants of its own
- K130202: Iris Anterior Cervical Plate (2013), 21 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own

## Indications for use
The X-Spine ACP System is intended for anterior screw fixation to the cervical spine. 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), * Tumors, * Deformity (defined as kyphosis, lordosis, or scoliosis) * Pseudoarthrosis, and/or * Failed previous fusions.

Source page: https://510kreport.com/device/K041469
Methodology: https://510kreport.com/methodology