# K063544: Modification to Pyrenees Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Feb 14, 2007 after 82 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: 2 generations back to K926453 (1993). 8 ancestors in all.
38 later devices descend from it; 8 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060442: Pyrenees Cervical Plate System, K2m, LLC (2006) Summary page 1.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1.
- K000538: Mallory/Head Lateralized Press-Fit Femoral, Biomet, Inc. (2000) Summary page 1.
- K051531: Tectonic Cervical Plate System, K2m, LLC (2005) Summary page 1.
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997) Summary page 1.
- K002592: Interpore Cross Anterior Cervical Plate System, Interpore Cross Intl. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K926486: De Puy Acromed PEAK Cervical Plate System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- 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
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own

## Indications for use
The Pyrenees Cervical Plate System is 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/K063544
Methodology: https://510kreport.com/methodology