# K130194: Acculif XL Cage

- Pathway: 510(k) (Special)
- Applicant: Coalign Innovations, Inc.
- Decided: Apr 3, 2013 after 65 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: 14 generations back to K841189 (1984). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123281: Acculif TL-Peek Cage, Coalign Innovations, Inc. (2013) Summary page 2.
- K113465: Acculif TL Cage, Coalign Innovations, Inc. (2011) Summary page 2.
- K093669: Sec Ibf Cage, Innvotec Surgical, Inc. (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K216835: AccuL-IF TL Cage. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3.

## Most influential descendants
- K131443: Coalign Innovations Acculif XL Ibf Cage (2013), 0 descendants of its own

## Indications for use
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLiF XL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (ODD) at one level or two contiguous levels from L2 to SI1. DOD 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 I 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 AccuLiF 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/K130194
Methodology: https://510kreport.com/methodology