# K142030: STGC-Lordotic

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Spine, LLC
- Decided: Jan 23, 2015 after 182 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- 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: 11 generations back to K841189 (1984). 38 ancestors in all.
58 later devices descend from it; 1 cites it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121176: STGC, Cardinal Spine, LLC (2012) Summary page 5.
- K131724: Pioneer Maxfuse Vertebral Body Replacement Device, Pioneer Surgical Technology, Inc. (2013) Summary page 5.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 5.

## Most influential descendants
- K152568: C-VBR (2016), 57 descendants of its own
- K162315: FORTIFY Corpectomy Spacers (2017), 55 descendants of its own
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System (2018), 28 descendants of its own
- K183510: T2 STRATOSPHERE Expandable Corpectomy System (2019), 27 descendants of its own
- K191066: CD Horizon™ Astute™ Spinal System (2019), 21 descendants of its own

## Indications for use
STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

Source page: https://510kreport.com/device/K142030
Methodology: https://510kreport.com/methodology