510(k) · Cleared
ClearedOpticage 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 Jan 20, 2012 as substantially equivalent to K080537 (Kiscomedica S.A., 2008) and 1 other predicate after a 51-day review. Its family tree reaches back 11 generations to 1984. 103 later devices descend from it.
- Decided
- Jan 20, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K841189 (1984). 21 ancestors in all. 103 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- Descendant · cites it directly · 72 of its ownK153400 ProLift Expandable SystemLife Spine, Inc. · 2016
- Descendant · 2 generations on · 37 of its ownK173182 ProLift® Expandable SystemLife Spine, Inc. · 2017
- Descendant · 2 generations on · 29 of its ownK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- Descendant · 3 generations on · 25 of its ownK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- Descendant · cites it directly · 25 of its ownK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K153400ProLift Expandable SystemLife Spine, Inc. · 2016 · cites it directly72descendants
- K173182ProLift® Expandable SystemLife Spine, Inc. · 2017 · 2 generations on37descendants
- K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017 · 2 generations on29descendants
- K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018 · 3 generations on25descendants
- K123461Staxx (R) IB SystemSpine Wave, Inc. · 2013 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| +1 | K153400 | ProLift Expandable System | Life Spine, Inc. | 2016 | — |
| +2 | K173182 | ProLift® Expandable System | Life Spine, Inc. | 2017 | — |
| +2 | K162918 | Atlas Spine Expandable Interbody System | Atlas Spine, Inc. | 2017 | — |
| +3 | K172696 | FORZA® XP Expandable Spacer System | Orthofix, Inc. | 2018 | — |
| +1 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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? (2)
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 |
|---|---|---|---|
| * | K080537 | L-VarlockSummary page 1…DEVICE Class 11 CLASSIFICATION: REGULATION 888.3080 (product code: MAX) NUMBER PREDICATE DEVICES: L-Varlock Lumbar Cage (K080537) Caliber Spacer (K 102293) Substantially Equivalent To The Opticage Interbody Fusion Device is subst… | 2008 |
| * | K102293 | Caliber SpacerSummary page 1…ION: REGULATION 888.3080 (product code: MAX) NUMBER PREDICATE DEVICES: L-Varlock Lumbar Cage (K080537) Caliber Spacer (K 102293) Substantially Equivalent To The Opticage Interbody Fusion Device is substantially equivalent in intended use, principal of ope… | 2011 |
What descends from it? (103)
See all 1038 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153400 | ProLift Expandable System | 2016 | 72 |
| K123461 | Staxx (R) IB System | 2013 | 25 |
| K160959 | Xsert Lumbar Expandable Interbody System | 2016 | 12 |
| K162879 | Elite Expandable Interbody Fusion Device | 2017 | 9 |
| K171425 | Concorde Lift | 2017 | 8 |
| K202298 | Lucent XP, Lucent XP Curved | 2020 | 2 |
| K234150 | Lucent® XP | 2024 | 0 |
| K133583 | Opticage Interbody Fusion Device, Model Series 9070 | 2014 | 0 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K153400 (Life Spine, Inc., 2016) has gone furthest, with 72 descendants of its own.
- 12 other devices also cite its predicate K080537.
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. 2012, 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-S 1. 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 or transforaminal approach. DDD is defined…
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-S 1. 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 or transforaminal 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 summary.
https://510kreport.com/device/K113527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113527: Opticage 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/K113527
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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