# K092108: Truss Thoracolumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Aug 13, 2009 after 30 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: 6 generations back to K990745 (1999). 14 ancestors in all.
42 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062407: Gateway Thoracolumbar Plate System, Globus Medical, Inc. (2006) Summary page 1.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K120092: Plymouth Thoracolumbar Plate System (2012), 41 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K140260: Skyhawk Lateral Plate System (2014), 14 descendants of its own
- K172131: 2 Hole Lateral Plating System (2017), 10 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own

## Indications for use
The TRUSS T M Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) 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 failed previous spine surgery.

Source page: https://510kreport.com/device/K092108
Methodology: https://510kreport.com/methodology