# K110270: Acculif Cage

- Pathway: 510(k) (Special)
- Applicant: Coalign Innovations, Inc.
- Decided: Apr 7, 2011 after 66 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: 1 generation back to K093669 (2010). 1 ancestor in all.
743 later devices descend from it; 2 cite it directly.
1 of 745 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093669: Sec Ibf Cage, Innvotec Surgical, Inc. (2010) Summary page 2.

## Most influential descendants
- K113465: Acculif TL Cage (2011), 718 descendants of its own
- K121683: Acculif TL Cage (2012), 682 descendants of its own
- K123752: Acculif TL and PL Cage (2013), 676 descendants of its own
- K132505: Acculif TL and PL Cage (2013), 645 descendants of its own
- K141217: Acculif TL and PL Cage (2014), 642 descendants of its own

## Indications for use
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLiF 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 OIDD 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 device is to be used with supplemental fixation. Vertebral Body Replacement: When used as a vertebral body replacement, CoAlign Innovations AccuLiF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (TI to LS) to replace or restore height a collapsed, damaged, diseased, or unstable portion. of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The CoAlign Innovations AccuLiF Cage is designed -to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

Source page: https://510kreport.com/device/K110270
Methodology: https://510kreport.com/methodology