# K181543: Cure™ OPEL-C Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Spine, LLC
- Decided: Aug 31, 2018 after 80 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: 3 generations back to K926453 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160604: Cure™ Anterior Cervical Plate (ACP) System, Meditech Spine, LLC (2016) Summary page 4.

## Most influential descendants
- K200523: Biolign® Roto-Loc Cervical Plate System (2020), 0 descendants of its own

## Indications for use
The Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spine 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), Deformity (defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.

Source page: https://510kreport.com/device/K181543
Methodology: https://510kreport.com/methodology