# K142980: Proficient (TM) Facet Screw Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jan 16, 2015 after 93 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: 5 generations back to K953076 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 4.
- K120340: Venus Facet Screw System, Apollo Spine, Inc. (2012) Summary page 4.
- K052043: 3.8MM CS Facet Compression Device, Triage Medical, Inc. (2005) Summary page 4.

## Indications for use
The Proficient™ Facet Screw Spine 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 S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine 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 • Spondylolisthesis • Spondylolysis • Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies • Degeneration of the facets with instability • Trauma including spinal fractures and/or dislocations

Source page: https://510kreport.com/device/K142980
Methodology: https://510kreport.com/methodology