# K100698: STCC

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Spine, LLC
- Decided: Mar 14, 2011 after 368 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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). 34 ancestors in all.
346 later devices descend from it; 1 cites it directly.
0 of 381 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 2.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 2.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 2.

## Most influential descendants
- K111439: Chesapeake (Cervical Components) (2011), 345 descendants of its own
- K133494: Chesapeake Spinal System (2014), 330 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K162264: Cascadia Interbody System (2016), 169 descendants of its own
- K171140: Matrixx System (2017), 145 descendants of its own

## Indications for use
The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

Source page: https://510kreport.com/device/K100698
Methodology: https://510kreport.com/methodology