510(k) · Cleared
ClearedVentana® P/T Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 15, 2026 as substantially equivalent to K203254 (Spinal Elements, Inc., 2021) after an 87-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- May 15, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to P980048 (2001). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 5 generations backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- 4 generations backK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- 3 generations backK122967 LucentSpinal Elements, Inc. · 2013
- 2 generations backK150061 Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc. · 2015
- 1 generation backK203254 Lucent 3D Spinal SystemSpinal Elements, Inc. · 2021
- This deviceK260506 Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −5 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| −4 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| −3 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
| −2 | K150061 | Lucent; Lucent Ti-Bond Systems | Spinal Elements, Inc. | 2015 | — |
| −1 | K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | 2021 | — |
| 0 (this device) | K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203254 | Lucent 3D Spinal SystemSummary page 5…Intervertebral Body) Device Product Code MAX Proposed Regulatory Class Class II Primary Predicate Devices K203254 Lucent 3D III. DEVICE DESCRIPTION The Ventana® P/T Lumbar Interbody devices are intervertebral body fusion device for use… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203254.
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. 2026, 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?
Ventana devices are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a…
Read the full statement (158 words)
Ventana devices are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months’ non-operative treatment prior to being treated with these devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260506: Ventana® P/T Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260506
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026