# K143616: AccuLIF TL and PL Cage

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Mar 5, 2015 after 76 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K841189 (1984). 120 ancestors in all.
469 later devices descend from it; 3 cite it directly.
0 of 590 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Stryker Corporation (2015). Cleared while this submission was under review Summary page 4.
- K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.

## Most influential descendants
- K152304: Tritanium PL Cage (2015), 448 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K160955: Tritanium® PL Cage (2016), 178 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
- Dec 16, 2015 · Class II · Z-0852-2016: There were two potential interference conditions identified with the way the tubing set attaches to the inserter.

## Indications for use
The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Source page: https://510kreport.com/device/K143616
Methodology: https://510kreport.com/methodology