# K111135: Pyrenees Cervical Plate System (Translational Plates)

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Aug 17, 2011 after 117 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 K031276 (2003). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 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 1.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K051665: Synthes Vectra-T System, Synthes Spine (2005) Summary page 1.

## Most influential descendants
- K142212: Pyrenees Cervical Plate System (2015), 0 descendants of its own

## Indications for use
The Pyrenees and 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), 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/K111135
Methodology: https://510kreport.com/methodology