# K021461: Atlantis Vision Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jul 22, 2002 after 76 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
No predicates in its family tree.
157 later devices descend from it; 14 cite it directly.
0 of 158 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 its predicate without a number.
- (no number) ATLANTIS Anterior Cervical Plate System: named in the summary without a submission number

## Most influential descendants
- K131025: Archon Anterior Cervical Plate System (2013), 97 descendants of its own
- K161442: NuVasive® CoRoent® Small Interlock™ System (2016), 94 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K063100: Atlantis Anterior Cervical Plate System, Translational Plate (2007), 50 descendants of its own
- K180909: REVEL Spacers (2018), 37 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 fixation of the cervical spine. 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/K021461
Methodology: https://510kreport.com/methodology