# K994239: Zephir Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jun 19, 2000 after 186 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.
165 later devices descend from it; 16 cite it directly.
0 of 166 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
- K012184: Blackstone Iii Anterior Cervical Plating System (2002), 85 descendants of its own
- K030595: Blackstone Fusion Anterior Cervical Plating System (2003), 66 descendants of its own
- K050892: Hallmarktm Anterior Cervical Plate System (2005), 52 descendants of its own
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates (2010), 51 descendants of its own
- K061002: Maxima Anterior Cervical Plate System (2006), 44 descendants of its own

## Indications for use
The ZEPHIR™ 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/K994239
Methodology: https://510kreport.com/methodology