# K140066: Infill Cervical

- Pathway: 510(k) (Traditional)
- Applicant: Pinnacle Spine Group, LLC
- Decided: May 5, 2014 after 115 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: 9 generations back to K841189 (1984). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083637: Calix Spinal Implant System, X-Spine Systems, Inc. (2009) Summary page 1.
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 2.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 1.

## Indications for use
The InFill® cervical interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.

Source page: https://510kreport.com/device/K140066
Methodology: https://510kreport.com/methodology