# K173476: Tritanium® TL Curved Posterior Lumbar Cage

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jan 18, 2018 after 70 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K151726: AVS AL and AVS ALign PEEK Spacers, AVS PL  and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer, Stryker Corporation (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K162262: Tritanium® PL Cage, Stryker (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K171496: Tritanium C Anterior Cervical Cage, Stryker Spine (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K183249: Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage (2019), 6 descendants of its own
- K200613: Tritanium® X TL Expandable Curved Posterior Lumbar Cage (2020), 5 descendants of its own
- K201585: Monterey AL Interbody System (2020), 4 descendants of its own
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (2025), 1 descendant of its own
- K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own

## Indications for use
The Stryker Spine Tritanium® TL 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 TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Tritanium TL Cage is to be implanted via a posterior approach. The Tritanium TL 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/K173476
Methodology: https://510kreport.com/methodology