# K113518: Arena-C Cervical Intervertebral Body Fusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Spinefrontier, Inc.
- Decided: Feb 16, 2012 after 79 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: 8 generations back to K841189 (1984). 32 ancestors in all.
193 later devices descend from it; 2 cite it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.

## Most influential descendants
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device (2014), 190 descendants of its own
- K152515: TOMCAT Cervical Spinal System (2015), 108 descendants of its own
- K170953: Tomcat Cervical Spinal System (2017), 103 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own

## Indications for use
The Arena-C Cervical Intervertebral Body Fusion System is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DOD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The SpineFrontier Arena-C Cervical Intervertebral Body Fusion System is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Antieror Cervical Plate Fixation). Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K113518
Methodology: https://510kreport.com/methodology