# K152304: Tritanium PL Cage

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 19, 2015 after 97 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 121 ancestors in all.
448 later devices descend from it; 10 cite it directly.
0 of 570 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). Our OCR of the scanned summary read K141363, FDA’s number for Centros Long Term Hemodialysis Catheter, Centrosflo Long… (Merit Medical Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stryker Spine AVS® PL and AVS® UniLIF™”.
- K143616: AccuLIF TL and PL Cage, Stryker Corporation (2015) Summary page 4.

## Most influential descendants
- 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
- K162264: Cascadia Interbody System (2016), 169 descendants of its own

## Recalls of this device
- Nov 28, 2018 · Class II · Z-0605-2019: The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.

## Indications for use
The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Tritanium® PL Cage is to be implanted via a posterior approach. The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K152304
Methodology: https://510kreport.com/methodology