# K192678: Genesys Spine Binary® Lumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Oct 24, 2019 after 28 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: 9 generations back to K990745 (1999). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173885: Genesys Spine Binary Lumbar Plate System, Genesys Spine (2018) Summary page 4.

## Most influential descendants
- K251940: PathLoc Lumbar Plate System (2026), 0 descendants of its own

## Indications for use
The Genesys Spine Binary® Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (I.1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K192678
Methodology: https://510kreport.com/methodology