# K133245: Genesys Spine Anterior Cervical Plate II System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Oct 8, 2014 after 351 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K922087 (1992). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111132: Genesys Spine Anterior Cervical Plate System, Genesys Spine (2011) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 4.
- K130427: Pioneer Aspect Anterior Cervical Plate System, Pioneer Surgical Technology, Inc. (2013) Summary page 4.

## Most influential descendants
- K192076: Binary® Anterior Cervical Plate System (2019), 0 descendants of its own

## Recalls of this device
- Nov 5, 2015 · Class II · Z-0040-2018: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.

## Indications for use
The Genesys Spine Anterior Cervical Plate II System 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 C7). 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), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

Source page: https://510kreport.com/device/K133245
Methodology: https://510kreport.com/methodology