# K121176: STGC

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Spine, LLC
- Decided: Aug 17, 2012 after 121 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: 10 generations back to K841189 (1984). 28 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 2.
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 2.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 2.

## Most influential descendants
- K142030: STGC-Lordotic (2015), 58 descendants of its own
- 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

## Indications for use
The STGC 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). The STGC 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/K121176
Methodology: https://510kreport.com/methodology