# K130640: Atlantis Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 4, 2013 after 85 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: 6 generations back to K953730 (1995). 14 ancestors in all.
32 later devices descend from it; 7 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 2.
- K081038: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek (2008) Summary page 2.

## Most influential descendants
- K141632: Zevo (TM) Anterior Cervical Plate System (2014), 18 descendants of its own
- K141599: Divergence Anterior Cervical Fusion System (2015), 16 descendants of its own
- K140417: Divergence Mini-Plate Anterior Cervical Fusion System (2014), 11 descendants of its own
- K152623: ATLANTIS Anterior Cervical Plate System (2015), 9 descendants of its own
- K182885: Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System (2019), 8 descendants of its own

## Indications for use
The ATLANTIS ® Anterior Cervical plate system is intended for anterior interbody screw fixation from C2 to T in the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographié studies). 2) trauma (including fractures), 3) tumors. 4) deformity (defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis. and/or 6) failed previous fusions. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K130640
Methodology: https://510kreport.com/methodology