# K161641: LOSPA IS ACP System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Jan 5, 2017 after 205 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 K021461 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063100: Atlantis Anterior Cervical Plate System, Translational Plate, Medtronic Sofamor Danek, Inc. (2007) Summary page 6.
- K010115: Reflex Anterior Cervical Plate System, Howmedica Osteonics Corp. (2001) Summary page 6.

## Indications for use
LOSPA IS ACP System is intended for anterior intervertebral 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 following indication: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2) Trauma (including fractures) 3) Tumors 4) Deformities or curvatures (including kyphosis, lordosis or scoliosis) 5) Pseudoarthrosis 6) Failed previous fusion.

Source page: https://510kreport.com/device/K161641
Methodology: https://510kreport.com/methodology