# K192314: RESONATE Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Oct 23, 2019 after 58 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: 8 generations back to K953730 (1995). 31 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092146: Xtend Anterior Cervical Plate System, Globus Medical, Inc. (2009) Summary page 4.
- K040721: Assure Anterior Cervical Plate System, Globus Medical, Inc. (2004) Summary page 4.
- K121049: Unify Dynamic Anterior Cervical Plate System, Globus Medical, Inc. (2012) Summary page 4.
- K141632: Zevo (TM) Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K231251: FlexWing Anterior Cervical Plate System (2024), 2 descendants of its own
- K252826: ARIX Femur Nail System (2025), 0 descendants of its own
- K251431: FIX-C PEEK ACIF SA System (2025), 0 descendants of its own

## Indications for use
The RESONATE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K192314
Methodology: https://510kreport.com/methodology