# K141632: Zevo (TM) Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 4, 2014 after 169 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K953730 (1995). 17 ancestors in all.
18 later devices descend from it; 7 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 5.
- K130640: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 6.
- K081038: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek (2008) Summary page 6.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 6.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 6.

## Most influential descendants
- 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
- 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
- K192314: RESONATE Anterior Cervical Plate System (2019), 3 descendants of its own
- K231251: FlexWing Anterior Cervical Plate System (2024), 2 descendants of its own

## Recalls of this device
- Mar 23, 2018 · Class II · Z-1750-2018: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

## Indications for use
The ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. 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) pseudoathrosis, and/or 6) failed previous fusions.

Source page: https://510kreport.com/device/K141632
Methodology: https://510kreport.com/methodology