# K132505: Acculif TL and PL Cage

- Pathway: 510(k) (Special)
- Applicant: Coalign Innovations, Inc.
- Decided: Sep 12, 2013 after 31 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K841189 (1984). 61 ancestors in all.
645 later devices descend from it; 2 cite it directly.
0 of 707 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123752: Acculif TL and PL Cage, Coalign Innovations, Inc. (2013) Summary page 2.

## Most influential descendants
- 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
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own
- K152304: Tritanium PL Cage (2015), 448 descendants of its own
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 descendants of its own

## Recalls of this device
- Jul 26, 2016 · Class II · Z-2788-2016: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence ra
- Jul 26, 2016 · Class II · Z-2786-2016: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence ra
- Jul 26, 2016 · Class II · Z-2787-2016: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence ra

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

Source page: https://510kreport.com/device/K132505
Methodology: https://510kreport.com/methodology