# K062407: Gateway Thoracolumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Sep 6, 2006 after 20 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: 5 generations back to K990745 (1999). 13 ancestors in all.
127 later devices descend from it; 3 cite it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.
- K973060: Depuy Motech Profile Anterior Thoracolumbar Plate System, Depuy, Inc. (1997) Summary page 1.

## Most influential descendants
- K100061: Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX (2010), 73 descendants of its own
- K131533: Cayman MI Plate System (2013), 72 descendants of its own
- K172941: CASCADIA Interbody System (2018), 52 descendants of its own
- K062836: Citadel Anterior Lumbar Plate System (2006), 50 descendants of its own
- K142699: LITe Plate System (2014), 46 descendants of its own

## Indications for use
The GATEWAY TM Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-5) 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/K062407
Methodology: https://510kreport.com/methodology