# K120340: Venus Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Spine, Inc.
- Decided: Oct 19, 2012 after 259 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953076 (1997). 12 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052043: 3.8MM CS Facet Compression Device, Triage Medical, Inc. (2005) Summary page 2.
- K092568: Spartan S3 Facet System, Amendia, Inc. (2009) Summary page 2.
- K100154: Fixcet Spinal Facet Screw System, X-Spine Systems, Inc. (2010) Summary page 2.

## Most influential descendants
- K163374: ALLY™ Facet Screws (2017), 18 descendants of its own
- K211855: Ion Facet Screw System (2022), 10 descendants of its own
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (2023), 9 descendants of its own
- K183589: PMT Facet Screw (2019), 8 descendants of its own
- K220951: PMT Facet Fixation System (PMT FFS) (2022), 7 descendants of its own

## Indications for use
The Apollo Spine Venus Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to SI for 4.5mm and 5.5 mm screws. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Apollo Venus Facet Screw System is indicated for treatment of any or all of the following: * Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity * Spondyldlisthesis * Spondylolysis * Degenerative disk disease (DDD) as defined by neck and/or back pain of discogenic origin as confinmed by radiographic studies * Degeneration of the facets with instability * Trauma including spinal fractures and/or dislocations

Source page: https://510kreport.com/device/K120340
Methodology: https://510kreport.com/methodology