# K040721: Assure Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 17, 2004 after 90 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: 1 generation back to K926453 (1993). 4 ancestors in all.
178 later devices descend from it; 7 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997). Our reading of the summary gave K971130, FDA’s number for Defend Fluid Resistant Pleated Mask (Carl Parker Associates, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Depuy PEAK”. Summary page 2.
- K031702: Reflex Anterior Cervical Plate System, Howmedica Osteonics (2003) Summary page 1.

## Most influential descendants
- K070775: Modification to: Providence Anterior Cervical Plate System (2007), 177 descendants of its own
- K081391: Vip Anterior Cervical Plate System (2008), 171 descendants of its own
- K142218: Coalition AGX Plate and Coalition AGX Spacer (2015), 155 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers (2018), 97 descendants of its own

## Indications for use
The ASSURETM 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 (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K040721
Methodology: https://510kreport.com/methodology