510(k) · Cleared
ClearedT-Rex Standalone ALIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siats, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Sep 7, 2017 after a 169-day review. The summary cites 4 numbers, none of which could be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Sep 7, 2017
- Review
- 169 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
4 later devices descend from it, 1 citing it directly.
- This deviceK170855 T-Rex Standalone ALIFSiats, LLC · 2017
- Descendant · cites it directly · 3 of its ownK193645 nva, nvp, and nvtNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK212477 EARP Interbody SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242457 EARP Interbody SystemRetropsoas Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc. · 2020 · cites it directly3descendants
- K212477EARP Interbody SystemNvision Biomedical Technologies, Inc. · 2022 · 2 generations on1descendant
- K242457EARP Interbody SystemRetropsoas Technologies, LLC · 2024 · 2 generations on0descendants
- K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170855 | T-Rex Standalone ALIF | Siats, LLC | 2017 | — |
| +1 | K193645 | nva, nvp, and nvt | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +2 | K242457 | EARP Interbody System | Retropsoas Technologies, LLC | 2024 | — |
| +2 | K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 | K141942 | FDA’s K141942 is Midline II TI Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2014 |
| Kept off the family tree | K151785 | FDA’s K151785 is Px HA PEEK IBF System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| Kept off the family tree | K162351 | FDA’s K162351 is SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device 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 | K170511 | FDA’s K170511 is NeoFuse HA Enhanced PLIF/TLIF 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193645 | nva, nvp, and nvt | 2020 | 3 |
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, K193645 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level(s). The…
Read the full statement (123 words)
When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion
in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer
component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/
or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with
the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170855: T-Rex Standalone ALIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170855
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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