# K121049: Unify Dynamic Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jun 27, 2012 after 82 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: 5 generations back to K926453 (1993). 17 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040721: Assure Anterior Cervical Plate System, Globus Medical, Inc. (2004) Summary page 1.
- K070775: Modification to: Providence Anterior Cervical Plate System, Globus Medical, Inc. (2007) Summary page 1.
- K092146: Xtend Anterior Cervical Plate System, Globus Medical, Inc. (2009) Summary page 1.
- K063100: Atlantis Anterior Cervical Plate System, Translational Plate, Medtronic Sofamor Danek, Inc. (2007) Summary page 1.
- K051665: Synthes Vectra-T System, Synthes Spine (2005) Summary page 1.

## Most influential descendants
- K133567: Unify (R) Dynamic Anterior Cervical Plate System (2014), 5 descendants of its own
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (2018), 4 descendants of its own
- K192314: RESONATE Anterior Cervical Plate System (2019), 3 descendants of its own
- K231251: FlexWing Anterior Cervical Plate System (2024), 2 descendants of its own
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own

## Indications for use
The UNIFYTM Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) 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/K121049
Methodology: https://510kreport.com/methodology