# K252711: Advantage-C™ Ti3D Cervical Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Intelivation Technologies
- Decided: Jan 8, 2026 after 134 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: 23 generations back to K841189 (1984). 278 ancestors in all.
No later device cites it as a predicate yet.
1 of 279 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211501: Advantage-C PEEK Cervical lnterbody Fusion Device, Lntelivation, LLC (2021) Summary page 5.
- K191354: Ti3Z Cervical Interbody System, Zavation Medical Products, LLC (2019) Summary page 5.

## Indications for use
The Advantage-C Ti 3D Cervical Interbody Fusion Device is a cervical Interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as diagnostic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Advantage-C Ti 3D Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. Advantage-C Ti 3D Cervical Interbody Fusion Device is supplied non-sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K252711
Methodology: https://510kreport.com/methodology