# K250446: Frida™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spineup, Inc.
- Decided: May 23, 2025 after 98 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: 11 generations back to K990745 (1999). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160702: ZION Anterior Cervical Fixation System, Astura Medical (2016) Summary page 5.
- K222572: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, Dio Medical Corporation (2022) Summary page 5.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 5.

## Indications for use
The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.

Source page: https://510kreport.com/device/K250446
Methodology: https://510kreport.com/methodology