# K080191: Eagle Plus Micro Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Apr 2, 2008 after 68 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: 3 generations back to K971730 (1997). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070994: Eagle + Anterior Cervical Plate System, Depuy Spine, Inc. (2007) Summary page 1.
- K914362: Top Cervical Spine Plates & Titanium Bone Screws, Acorn Group, Inc. (1992) Summary page 1.

## Most influential descendants
- K153526: Pyrenees Cervical Plate System (2016), 6 descendants of its own
- K162664: Pyrenees Cervical Plate System (2016), 5 descendants of its own
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems (2018), 4 descendants of its own
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (2024), 1 descendant of its own
- K221728: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate (2022), 1 descendant of its own

## Indications for use
The EAGLE Plus Micro Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is 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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Source page: https://510kreport.com/device/K080191
Methodology: https://510kreport.com/methodology
