# K211501: Advantage-C PEEK Cervical lnterbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Lntelivation, LLC
- Decided: Aug 24, 2021 after 102 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: 15 generations back to K841189 (1984). 84 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111983: Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 4.
- K133784: Vista-S Device, Associated Instrumentation, Zimmer Trabecular Metal Technology (2014) Summary page 4.
- K162206: Zavation IBF, Zavation, LLC (2017) Summary page 4.

## Most influential descendants
- K252711: Advantage-C™ Ti3D Cervical Interbody Fusion Device (2026), 0 descendants of its own

## Indications for use
The Advantage-C PEEK 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 discogenic 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 PEEK Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft.. The Advantage-C PEEK Cervical Interbody Fusion Device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K211501
Methodology: https://510kreport.com/methodology