# K153526: Pyrenees Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Apr 27, 2016 after 140 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: 5 generations back to K002592 (2000). 32 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063544: Modification to Pyrenees Cervical Plate System, K2m, Inc. (2007) Summary page 4.
- K040197: Eagle Anterior Cervial Plate System, Depuyacromed (2004) Summary page 4.
- K080191: Eagle Plus Micro Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 4.
- K121060: Spine Frontier Indus Acp System, Spinefrontier, Inc. (2012) Summary page 4.
- K102265: LDR Spine Usa C-Plate, TL Anterior Cervical Plate System, Ldr Spine USA (2010) Summary page 4.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 4.

## Most influential descendants
- 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
- K253545: Vulcan Spinal System (2026), 0 descendants of its own

## Indications for use
Pyrenees and Blue Ridge Cervical Plate Systems are intended for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

Source page: https://510kreport.com/device/K153526
Methodology: https://510kreport.com/methodology