# K130948: C-Fuse Cervical Intervertebral Body Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Spine, LLC
- Decided: Aug 14, 2013 after 131 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: 11 generations back to K841189 (1984). 41 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083167: Phenix Cervical Interbody Device, Spinal Devices, LLC (2009) Summary page 1.
- K103660: Lanx Cervical Intervertebral Body Fusion System, Lanx, Inc. (2011) Summary page 1.

## Most influential descendants
- K141129: Exactech Cervical Spacer System (2014), 8 descendants of its own
- K150130: Ascendant TM Cervical Spacer System (2015), 7 descendants of its own
- K191621: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (2019), 4 descendants of its own
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System (2023), 2 descendants of its own

## Indications for use
The Southern Spine C-FuseTM Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.

Source page: https://510kreport.com/device/K130948
Methodology: https://510kreport.com/methodology