# K103137: Venus Anterior Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Verticor, Ltd.
- Decided: Feb 10, 2011 after 108 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: 5 generations back to K973854 (1998). 21 ancestors in all.
5 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)
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 1.
- K030500: Oria Zenith, Ortho Tec, LLC (2003) Summary page 1.
- K001535: Zenith Plate System, Anterior Spinal Instrumentation, Ortho Tec, LLC (2001) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K102820: Appliance, Fixation, Spinal Intervertebral Body, Alphatec Spine, Inc. (2010). Cleared while this submission was under review Summary page 1.
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 2.
- K033844: Synthes Anterior Cervical Compression System, Synthes (Usa) (2004) Summary page 2.
- (no number) SmartLOX Anterior Cervical Plate: named in the summary without a submission number

## Most influential descendants
- K111132: Genesys Spine Anterior Cervical Plate System (2011), 4 descendants of its own
- 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

## Indications for use
The VENUS 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), * spondylotisthesis, * trauma (i.e. fractures or dislocations), * tumors, * deformity (defined as kyphosis, lordlosis, or scoliosis), * pseudlarthrosis, * failed previous fusion, * spinal stenosis. WARNING: The VENUS Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K103137
Methodology: https://510kreport.com/methodology