510(k) · Cleared
ClearedSpine Wave Gen II Expandable Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 15, 2016 as substantially equivalent to K131071 (Spine Wave, Inc., 2013) and 9 other predicates after a 123-day review. Its family tree reaches back 16 generations to 1984. 2 later devices descend from it.
- Decided
- Jan 15, 2016
- Review
- 123 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 16 generations to K841189 (1984). 65 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK131071 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 2 generations backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 1 generation backK140007 Abacus TM Spacer SystemSpine Wave, Inc. · 2014
- This deviceK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK173175 Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 12 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 11 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 10 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 8 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 7 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 6 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 5 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 4 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 3 generations backK131071 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 2 generations backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 1 generation backK140007 Abacus TM Spacer SystemSpine Wave, Inc. · 2014
- This deviceK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −12 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −11 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −10 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −8 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −7 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −6 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −5 | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| −4 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
| −3 | K131071 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −2 | K132719 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −1 | K140007 | Abacus TM Spacer System | Spine Wave, Inc. | 2014 | — |
| 0 (this device) | K152620 | Spine Wave Gen II Expandable Interbody System | Spine Wave, Inc. | 2016 | — |
| +1 | K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +2 | K173175 | Paramount Anterior Cervical Cage System | Spine Wave, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 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? (10)
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 |
|---|---|---|---|
| * | K131071 | Staxx Ibl SystemSummary page 5…K152620 Device Manufacturer 510(k) No. Primary Predicate StaXx® IBL System Spine Wave, Inc. K131071 Additional Predicate StaXx® IBL System Spine Wave, Inc. K132719 Additional Predicate StaXx® IB… | 2013 |
| * | K132719 | Staxx Ibl SystemSummary page 5…510(k) No. Primary Predicate StaXx® IBL System Spine Wave, Inc. K131071 Additional Predicate StaXx® IBL System Spine Wave, Inc. K132719 Additional Predicate StaXx® IB Spine Wave, Inc K123461 Additional Predicate Caliber®/ Caliber… | 2013 |
| * | K123461 | Staxx (R) IB SystemSummary page 5…K131071 Additional Predicate StaXx® IBL System Spine Wave, Inc. K132719 Additional Predicate StaXx® IB Spine Wave, Inc K123461 Additional Predicate Caliber®/ Caliber L® Globus Medical Inc. K123231 Spacer Additi… | 2013 |
| * | K123231 | Caliber SpacersSummary page 5…K132719 Additional Predicate StaXx® IB Spine Wave, Inc K123461 Additional Predicate Caliber®/ Caliber L® Globus Medical Inc. K123231 Spacer Additional Predicate Patriot® Spacer Globus Medical Inc. K122097 Additi… | 2013 |
| * | K122097 | Patriot SpacersSummary page 5…te Caliber®/ Caliber L® Globus Medical Inc. K123231 Spacer Additional Predicate Patriot® Spacer Globus Medical Inc. K122097 Additional Predicate LDR Spine USA LDR Spine USA K113285 Avenue® L Interbod… | 2012 |
| * | K113285 | LDR Spine Usa Avenue L Interbody FusionSummary page 5…Spacer Additional Predicate Patriot® Spacer Globus Medical Inc. K122097 Additional Predicate LDR Spine USA LDR Spine USA K113285 Avenue® L Interbody Fusion System Additional Predicate Pezo ™ PEEK… | 2012 |
| * | K103814 | Pezo Interbody Cages SystemSummary page 5…3285 Avenue® L Interbody Fusion System Additional Predicate Pezo ™ PEEK Cage Ulrich GmbH & Co. K103814 Family KG Additional Predicate Abacus® Spacer Spine Wave, Inc.… | 2011 |
| * | K140007 | Abacus TM Spacer SystemSummary page 5…e Ulrich GmbH & Co. K103814 Family KG Additional Predicate Abacus® Spacer Spine Wave, Inc. K140007 System Additional Predicate Biomet Fusion System Biomet Spine K141791 Addi… | 2014 |
| * | K141791 | Biomet Fusion SystemSummary page 5…e Abacus® Spacer Spine Wave, Inc. K140007 System Additional Predicate Biomet Fusion System Biomet Spine K141791 Additional Predicate Synfix-LR SPACER Synthes Spine Co. LP K072253 5. Device Description The Gen II Exp… | 2014 |
| * | K072253 | Synfix-LR SpacerSummary page 5…System Additional Predicate Biomet Fusion System Biomet Spine K141791 Additional Predicate Synfix-LR SPACER Synthes Spine Co. LP K072253 5. Device Description The Gen II Expandable Interbody System is composed of wafers that are stacked into an expanda… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162760 | Spine Wave Anterior Cervical Spine System | 2017 | 1 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 10 of the 65 ancestors have a recall of any class.
- Of its descendants, K162760 (Spine Wave, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K131071.
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. 2016, 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 Spine Wave Gen Il Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by…
Read the full statement (123 words)
The Spine Wave Gen Il Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152620: Spine Wave Gen II Expandable 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/K152620
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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