# K190291: Addivation Medical Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Addivation Medical, LLC
- Decided: Jul 30, 2019 after 169 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: 22 generations back to K841189 (1984). 249 ancestors in all.
No later device cites it as a predicate yet.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171496: Tritanium C Anterior Cervical Cage, Stryker Spine (2017) Summary page 4.
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System, Orthofix, Inc. (2015) Summary page 4.

## Indications for use
The Addivation Medical Cervical Interbody System is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy. The Addivation Medical Cervical Interbody System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, and is to be implanted via an open, anterior approach. The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K190291
Methodology: https://510kreport.com/methodology