# K081038: Atlantis Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 15, 2008 after 126 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953730 (1995). 13 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970806: Acpii Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 2.
- K063100: Atlantis Anterior Cervical Plate System, Translational Plate, Medtronic Sofamor Danek, Inc. (2007) Summary page 2.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K130640: Atlantis Anterior Cervical Plate System (2013), 32 descendants of its own
- 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

## Recalls of this device
- Aug 30, 2012 · Class II · Z-0036-2013: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its a
- Aug 30, 2012 · Class II · Z-0038-2013: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its a
- Aug 30, 2012 · Class II · Z-0037-2013: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its a

## Indications for use
Properly used, this system is intended for anterior interbody screw/plate fixation from C2 to TI. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. 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 radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, 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/K081038
Methodology: https://510kreport.com/methodology