# K160522: White Pearl Preferred Angle Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems, LLC
- Decided: Apr 26, 2016 after 61 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: 15 generations back to K003155 (2001). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132012: Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate System, Zimmer Spine, Inc. (2013) Summary page 4.
- K060025: Slimplicity Anterior Cervical Plate System, Spinal USA (2006) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 4.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 4.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 4.
- K132894: Optio-C Anterior Cervical System, Zimmer Spine, Inc. (2014) Summary page 4.

## Indications for use
The White Pearl Preferred Angle Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

Source page: https://510kreport.com/device/K160522
Methodology: https://510kreport.com/methodology