# K112095: Acculif TL-Peek Ibf Cage

- Pathway: 510(k) (Traditional)
- Applicant: Coalign Innovations, Inc.
- Decided: Dec 1, 2011 after 132 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: 11 generations back to K841189 (1984). 23 ancestors in all.
319 later devices descend from it; 11 cite it directly.
0 of 343 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110270: Acculif Cage, Coalign Innovations, Inc. (2011) Summary page 2.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 2.
- K093669: Sec Ibf Cage, Innvotec Surgical, Inc. (2010) Summary page 2.

## Most influential descendants
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (2017), 199 descendants of its own
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages (2017), 159 descendants of its own
- K123281: Acculif TL-Peek Cage (2013), 146 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own
- K133813: Flxfit Intervertebral Body Fusion Device (2014), 137 descendants of its own

## Indications for use
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF® TL-PEEK 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 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 TL-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage is to be used with autogenous bone graft.

Source page: https://510kreport.com/device/K112095
Methodology: https://510kreport.com/methodology