# K993855: Atlantis Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Danek Medical, Inc.
- Decided: Dec 15, 1999 after 30 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
No predicates in its family tree.
295 later devices descend from it; 5 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K000486: Abc Cervical Plating System (2000), 289 descendants of its own
- K050813: Abc 2 Screw (2005), 145 descendants of its own
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K122910: Archon Anterior Cervical Plate Syste, (2012), 101 descendants of its own

## Indications for use
The ATLANTIS™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of 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 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, and/or failed previous fusions.

Source page: https://510kreport.com/device/K993855
Methodology: https://510kreport.com/methodology