510(k) · Cleared
ClearedTritanium® TL Curved Posterior Lumbar Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 18, 2018 after a 70-day review. The summary cites 3 numbers, none of which could be confirmed as its predicate (see the table below). 7 later devices descend from it.
- Decided
- Jan 18, 2018
- Review
- 70 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
7 later devices descend from it, 3 citing it directly.
- This deviceK173476 Tritanium® TL Curved Posterior Lumbar CageStryker · 2018
- Descendant · cites it directly · 6 of its ownK183249 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL…Stryker Spine · 2019
- Descendant · 2 generations on · 5 of its ownK200613 Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation · 2020
- Descendant · cites it directly · 4 of its ownK201585 Monterey AL Interbody SystemStryker Corporation · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK250072 CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine · 2019 · cites it directly6descendants
- K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation · 2020 · 2 generations on5descendants
- K201585Monterey AL Interbody SystemStryker Corporation · 2020 · cites it directly4descendants
- K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025 · 2 generations on1descendant
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K173476 | Tritanium® TL Curved Posterior Lumbar Cage | Stryker | 2018 | — |
| +1 | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable… | Stryker Spine | 2019 | — |
| +2 | K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Stryker Corporation | 2020 | — |
| +1 | K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 | 4 |
| +2 | K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025 | — |
| +1 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K151726 | FDA’s K151726 is AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2016 |
| Kept off the family tree | K162262 | FDA’s K162262 is Tritanium® PL Cage Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2016 |
| Kept off the family tree | K171496 | FDA’s K171496 is Tritanium C Anterior Cervical Cage Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2017 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K183249 (Stryker Spine, 2019) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173476: Tritanium® TL Curved Posterior Lumbar Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173476
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026