# K112809: Blue Mountain Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Qualgenix, LLC
- Decided: Jun 20, 2012 after 267 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 K922087 (1992). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 2.
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000) Summary page 2.
- K010466: Tether Acfs, Theken Surgical,Llc (2001) Summary page 2.
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 2.
- K042235: Orion Anterior Cervical Plating System, Medtronic Sofamor Danek (2004) Summary page 2.
- K993855: Atlantis Anterior Cervical Plate System, Danek Medical, Inc. (1999) Summary page 2.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 2.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 2.
- K001794: Ebi Anterior Cervical Plate System, Ebi, L.P. (2000) Summary page 2.
- K012881: C3 Anterior Cervical Plate System, Spine Vision, Inc. (2001) Summary page 2.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- K150036: Blue Mountain Cervical Plate System (2015), 1 descendant of its own
- K163602: Kepler I Cervical Plate System (2017), 0 descendants of its own

## Indications for use
The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudloarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedlicles) of the cervical; thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Source page: https://510kreport.com/device/K112809
Methodology: https://510kreport.com/methodology