# K120092: Plymouth Thoracolumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Apr 13, 2012 after 93 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: 7 generations back to K990745 (1999). 20 ancestors in all.
41 later devices descend from it; 8 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092108: Truss Thoracolumbar Plate System, Globus Medical, Inc. (2009) Summary page 1.
- K091071: Nuvasive Lateral Plate System, Nuvasive, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K180166: Life Spine Lumbar Fixation System (SENTRY) (2018), 9 descendants of its own

## Indications for use
The PLYMOUTH Tm 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/K120092
Methodology: https://510kreport.com/methodology