510(k) · Cleared
Recalled · Class II · 2019Opticage Expandable Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interventional Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 19, 2015 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 19, 2015
- Review
- 77 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK152156 Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK160464 Opticage (R) Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2016 · Recalled
- Descendant · cites it directly · 8 of its ownK171425 Concorde LiftMedos International SARL · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
- Descendant · 3 generations on · 3 of its ownK203531 XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160464Opticage (R) Expandable Interbody Fusion DeviceInterventional Spine, Inc. · 2016 · cites it directly9descendants
- K171425Concorde LiftMedos International SARL · 2017 · cites it directly8descendants
- K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019 · 2 generations on5descendants
- K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc. · 2021 · 3 generations on3descendants
- K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K152156 | Opticage Expandable Interbody Fusion Device | Interventional Spine, Inc. | 2015 | — |
| +1 | K160464 | Opticage (R) Expandable Interbody Fusion Device | Interventional Spine, Inc. | 2016 | 2 |
| +1 | K171425 | Concorde Lift | Medos International SARL | 2017 | 2 |
| +2 | K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2019 | — |
| +3 | K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | 2021 | — |
| +4 | K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2019 | Class II | Z-1226-2019 | Under Investigation by firm | A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. |
| Nov 22, 2016 | Class II | Z-0941-2017 | Device Design | During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160464 (Interventional Spine, Inc., 2016) has gone furthest, with 9 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. 2015, 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 Opticage® Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD…
Read the full statement (165 words)
The Opticage® Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use
with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.
These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage
Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients
may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation
systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices
and posterior pedicle screw and rod systems).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K152156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152156: Opticage Expandable Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152156
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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