# K141333: Arena-C  Tifuse Cervical Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Nov 25, 2014 after 188 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: 12 generations back to K003155 (2001). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141337: Arena-C, Spinefrontier, Inc. (2014). Cleared while this submission was under review Summary page 6.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 6.
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 6.

## Indications for use
The SpineFrontier® Arena-C® TiFuse™ Cervical Intervertebral Body Fusion Device 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 (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The SpineFrontier® Arena-C® Cervical IBFD is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior 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/K141333
Methodology: https://510kreport.com/methodology