# K113465: Acculif TL Cage

- Pathway: 510(k) (Special)
- Applicant: Coalign Innovations, Inc.
- Decided: Dec 12, 2011 after 20 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.
718 later devices descend from it; 5 cite it directly.
1 of 742 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- 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
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (2015), 636 descendants of its own

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

Source page: https://510kreport.com/device/K113465
Methodology: https://510kreport.com/methodology