# K123281: Acculif TL-Peek Cage

- Pathway: 510(k) (Traditional)
- Applicant: Coalign Innovations, Inc.
- Decided: Jan 23, 2013 after 93 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: 13 generations back to K841189 (1984). 61 ancestors in all.
146 later devices descend from it; 7 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011)
- K121683: Acculif TL Cage, Coalign Innovations, Inc. (2012) Summary page 2.
- K113465: Acculif TL Cage, Coalign Innovations, Inc. (2011)

## Most influential descendants
- K133813: Flxfit Intervertebral Body Fusion Device (2014), 137 descendants of its own
- K153400: ProLift Expandable System (2016), 72 descendants of its own
- K171519: FLXfit™ (2017), 71 descendants of its own
- K180078: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System (2018), 55 descendants of its own
- K183064: TxTi IBF System (2019), 48 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 SI. 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/K123281
Methodology: https://510kreport.com/methodology