# K111132: Genesys Spine Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Dec 9, 2011 after 231 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: 6 generations back to K973854 (1998). 22 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K103137: Venus Anterior Cervical Plate, Verticor, Ltd. (2011) Summary page 1.
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 1.
- K102820: Appliance, Fixation, Spinal Intervertebral Body, Alphatec Spine, Inc. (2010) Summary page 1.
- (no number) SmartLox Anterior Cervical Plate: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K094570: Synthes Anterior CSP System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133245: Genesys Spine Anterior Cervical Plate II System (2014), 1 descendant of its own
- K131512: Katia System (2013), 1 descendant of its own
- K192076: Binary® Anterior Cervical Plate System (2019), 0 descendants of its own
- K163366: Shanghai Sanyou CARMEN Cervical Fusion System (2017), 0 descendants of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-0921-2013: Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surg

## Indications for use
The Genesys Spine Anterior Cervical Plate 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/K111132
Methodology: https://510kreport.com/methodology