# K060442: Pyrenees Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, LLC
- Decided: May 15, 2006 after 83 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
No predicates in its family tree.
40 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cervical Spine Locking Plate System: named in the summary without a submission number
- (no number) Tectonic Cervical Plate System: named in the summary without a submission number
- (no number) PEAK Anterior Cervical Plate System: named in the summary without a submission number

## Most influential descendants
- K063544: Modification to Pyrenees Cervical Plate System (2007), 38 descendants of its own
- K113329: K2M, Pyrenees Cervical Plate System (2012), 28 descendants of its own
- K130202: Iris Anterior Cervical Plate (2013), 21 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own

## Indications for use
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/K060442
Methodology: https://510kreport.com/methodology