# K040197: Eagle Anterior Cervial Plate System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Apr 2, 2004 after 64 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: 1 generation back to K971730 (1997). 1 ancestor in all.
215 later devices descend from it; 5 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997) Summary page 1.

## Most influential descendants
- K070994: Eagle + Anterior Cervical Plate System (2007), 204 descendants of its own
- K072546: Swift Plus Anterior Cervical Plate System (2007), 195 descendants of its own
- K080646: C-Tek Maxan Anterior Cervical Plate System (2008), 193 descendants of its own
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own

## Indications for use
The Eagle Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

Source page: https://510kreport.com/device/K040197
Methodology: https://510kreport.com/methodology