# K152623: ATLANTIS Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 12, 2015 after 59 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: 8 generations back to K953730 (1995). 18 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 28 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 4.
- K063100: Atlantis Anterior Cervical Plate System, Translational Plate, Medtronic Sofamor Danek, Inc. (2007) Summary page 4.
- K130640: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K141632: Zevo (TM) Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (2020), 4 descendants of its own
- K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own
- K241164: IB3D™ PL Spinal System (2024), 1 descendant of its own
- K253577: IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (2025), 0 descendants of its own

## Indications for use
Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. 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/K152623
Methodology: https://510kreport.com/methodology