# K152015: Pyrenees Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Sep 4, 2015 after 45 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: 4 generations back to K926453 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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.
- K150983: Pyrenees Cervical Plate System, K2m (2015) Summary page 4.

## Indications for use
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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/K152015
Methodology: https://510kreport.com/methodology