# K092474: Pyrenees Cervical Plate System, Semi-Constrained Screws

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Mar 11, 2010 after 211 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: 3 generations back to K926453 (1993). 16 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 25 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.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 1.
- K063100: Atlantis Anterior Cervical Plate System, Translational Plate, Medtronic Sofamor Danek, Inc. (2007) Summary page 1.
- K060379: Ebi Anterior Cervical Plate System, Ebi, L.P. (2006) Summary page 1.
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997) Summary page 1.
- K001046: Biopro Glenoid Component W/ Keel & W/ Posts, Biopro, Inc. (2000)

## Most influential descendants
- K152281: Pyrenees Cervical Plate System (2015), 6 descendants of its own
- K172104: Ozark (tm) Cervical Plate System (2017), 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

## 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, traumna (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudar-throsis) and deformity (defined as scoliosis, kyphosis or lordosis).

Source page: https://510kreport.com/device/K092474
Methodology: https://510kreport.com/methodology