# K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Dec 12, 2018 after 93 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: 8 generations back to K990745 (1999). 105 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172104: Ozark (tm) Cervical Plate System, K2m, Inc. (2017) Summary page 7.
- K162664: Pyrenees Cervical Plate System, K2m, Inc. (2016) Summary page 7.
- K113329: K2M, Pyrenees Cervical Plate System, K2m, Inc. (2012) Summary page 7.
- K131533: Cayman MI Plate System, K2m, Inc. (2013) Summary page 7.

## Most influential descendants
- 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
- K253545: Vulcan Spinal System (2026), 0 descendants of its own
- K230424: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (2023), 0 descendants of its own

## Indications for use
PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) 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). OZARK Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) 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). The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications. The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, ¢) spondylolysis, d) spondylolisthesis, €) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

Source page: https://510kreport.com/device/K182473
Methodology: https://510kreport.com/methodology