# K200523: Biolign® Roto-Loc Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Elite Surgical Supplies (Pty), Ltd.
- Decided: Apr 30, 2020 after 59 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012184: Blackstone Iii Anterior Cervical Plating System, Blackstone Medical, Inc. (2002) Summary page 4.
- K181543: Cure™ OPEL-C Plate System, Meditech Spine, LLC (2018) Summary page 4.

## Indications for use
The Biolign® Roto-Loc Anterior Cervical Plating System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: 1. Degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies) 2. Trauma (including fractures) 3. Tumor 4. Spondylolisthesis 5. Spinal stenosis 6. Deformity (i.e., scoliosis, kyphosis, lordosis) 7. Pseudarthrosis 8. Failed previous fusions

Source page: https://510kreport.com/device/K200523
Methodology: https://510kreport.com/methodology