# K131200: Aspiron Acp System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Aug 29, 2013 after 122 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: 4 generations back to K922087 (1992). 16 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061002: Maxima Anterior Cervical Plate System, U&I Corp. (2006) Summary page 1.
- K012184: Blackstone Iii Anterior Cervical Plating System, Blackstone Medical, Inc. (2002) Summary page 1.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K140234: Aspiron Acp System (2014), 6 descendants of its own
- K231251: FlexWing Anterior Cervical Plate System (2024), 2 descendants of its own
- K182055: SECULOK™ ACP System (2018), 2 descendants of its own
- K190053: SECULOK™ ACP System (2019), 1 descendant of its own
- K252826: ARIX Femur Nail System (2025), 0 descendants of its own

## Indications for use
The ASPIRON TM ACP System is intended for anterior inter-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, orilordosis) * Pseudloarthrosis * 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/K131200
Methodology: https://510kreport.com/methodology