# K131443: Coalign Innovations Acculif XL Ibf Cage

- Pathway: 510(k) (Special)
- Applicant: Coalign Innovations, Inc.
- Decided: Jun 19, 2013 after 30 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). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130194: Acculif XL Cage, Coalign Innovations, Inc. (2013) Summary page 2.
- K123281: Acculif TL-Peek Cage, Coalign Innovations, Inc. (2013) Summary page 2.

## Indications for use
The CoAlign Innovations AccuLIF XL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The CoAlign Innovations AccuLLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

Source page: https://510kreport.com/device/K131443
Methodology: https://510kreport.com/methodology