# K190053: SECULOK™ ACP System

- Pathway: 510(k) (Special)
- Applicant: U&I Corporation
- Decided: Feb 1, 2019 after 21 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: 7 generations back to K002592 (2000). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182055: SECULOK™ ACP System, U&I Corporation (2018) Summary page 4.
- K131200: Aspiron Acp System, U&I Corporation (2013) Summary page 4.
- K140234: Aspiron Acp System, U&I Corp. (2014) Summary page 4.

## Most influential descendants
- K220147: Aspiron S ACP System (2022), 0 descendants of its own

## Indications for use
The SECULOK™ ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies); Spondylolisthesis Trauma (including fractures, dislocation) Spinal stenosis Tumors Deformity (defined as scoliosis, kyphosis, or lordosis Pseudoarthrosis Failed previous fusion WARNING: The 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/K190053
Methodology: https://510kreport.com/methodology