510(k) · Cleared
ClearedX-Pac Expandable Lumbar Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Expanding Innovations, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 10, 2020 as substantially equivalent to K152539 (Spine View, Inc., 2016) and 2 other predicates after a 134-day review. Its family tree reaches back 15 generations to 1984. 4 later devices descend from it.
- Decided
- Sep 10, 2020
- Review
- 134 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 39 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- 2 generations backK152539 SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc. · 2016
- 1 generation backK160856 SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc. · 2016
- This deviceK201145 X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK203802 X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK220655 X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK222797 X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable…Expanding Innovations, Inc. · 2025
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 11 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 10 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 9 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 7 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 6 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 5 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 4 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
- 3 generations backK123231 Caliber SpacersGlobus Medical, Inc. · 2013
- 2 generations backK152539 SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc. · 2016
- 1 generation backK160856 SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc. · 2016
- This deviceK201145 X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2021 · cites it directly3descendants
- K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2022 · cites it directly2descendants
- K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc. · 2022 · cites it directly1descendant
- K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −11 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −10 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −9 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −7 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −6 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −5 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −4 | K113447 | Rise Spacer | Globus Medical, Inc. | 2012 | — |
| −3 | K123231 | Caliber Spacers | Globus Medical, Inc. | 2013 | — |
| −2 | K152539 | SpineView X-Pac Expandable Lumbar Cage System | Spine View, Inc. | 2016 | — |
| −1 | K160856 | SpineView X-Pac Expandable Lumbar Cage System | Spine View, Inc. | 2016 | — |
| 0 (this device) | K201145 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2020 | — |
| +1 | K203802 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2021 | — |
| +1 | K220655 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2022 | — |
| +1 | K222797 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2022 | — |
| +2 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral… | Expanding Innovations, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152539 | SpineView X-Pac Expandable Lumbar Cage SystemSummary page 4…The Expanding Innovations X-Pac Expandable Lumbar Cage System is substantially equivalent to the previously cleared X-Pac Expandable Lumbar Cage System, K152539 and K160856. F. Additional Predicate Device Titan Spine Inc., Endoskeleton TT, K083714 G. Device Description… | 2016 |
| * | K160856 | SpineView X-Pac Expandable Lumbar Cage SystemSummary page 4…anding Innovations X-Pac Expandable Lumbar Cage System is substantially equivalent to the previously cleared X-Pac Expandable Lumbar Cage System, K152539 and K160856. F. Additional Predicate Device Titan Spine Inc., Endoskeleton TT, K083714 G. Device Description The X-Pac Ex… | 2016 |
| * | K083714 | Endoskeleton TT Interbody Fusion Device (Ibd)Summary page 4…ent to the previously cleared X-Pac Expandable Lumbar Cage System, K152539 and K160856. F. Additional Predicate Device Titan Spine Inc., Endoskeleton TT, K083714 G. Device Description The X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a… | 2009 |
What descends from it? (4)
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?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 39 ancestors have a recall of any class.
- Of its descendants, K203802 (Expanding Innovations, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K152539.
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. 2020, 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 Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two…
Read the full statement (151 words)
The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion.
The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201145 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201145: X-Pac Expandable Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201145
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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