# K212389: Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF

- Pathway: 510(k) (Traditional)
- Applicant: Intelivation, LLC
- Decided: Oct 29, 2021 after 88 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121567: Oracle Lumbar Intervertebral Body Fusion Cage System, Accel Spine (2012) Summary page 4.
- K131981: Cezanne II Interbody Fusion System, Accel Spine (2013) Summary page 4.

## Indications for use
The Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K212389
Methodology: https://510kreport.com/methodology