# K020649: Envision Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Apr 5, 2002 after 36 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Anterior CSLP System: named in the summary without a submission number
- (no number) EBI Vuelock Anterior Cervical Plate System: named in the summary without a submission number
- (no number) Window Cervical Dynamic Plate System: named in the summary without a submission number

## Most influential descendants
- K103505: Altum Anterior Cervical Plate (2011), 1 descendant of its own
- K131521: Velox Anterior Cervical Plate System (2013), 0 descendants of its own

## Indications for use
The Envision™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Envision™ Anterior Cervical Plate System is intended for use under the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Spondylolisthesis Trauma (i.e., fracture) Tumor Deformity (i.e., kyphosis, lordosis, and scoliosis) Spinal stenosis Pseudarthrosis Failed previous fusion

Source page: https://510kreport.com/device/K020649
Methodology: https://510kreport.com/methodology