510(k) · Cleared
ClearedDIVERGENCE-L Anterior/Oblique Lumbar Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 11, 2015 as substantially equivalent to K131669 (Medtronic Sofamor Danek USA, Inc., 2013) and 9 other predicates after a 141-day review. Its family tree reaches back 15 generations to 2001. 1 of the 384 devices in its family, counting itself, has a Class I recall. 228 later devices descend from it.
- Decided
- Jun 11, 2015
- Review
- 141 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 15 generations to K003155 (2001). 155 ancestors in all, the oldest K792352 (1979). 228 later devices descend from it, 11 citing it directly. 1 of the 384 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- This deviceK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- Descendant · 3 generations on · 79 of its ownK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- Descendant · 4 generations on · 67 of its ownK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- Descendant · 4 generations on · 63 of its ownK181079 SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- This deviceK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 228 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 228 · See all- K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly190descendants
- K161379ELSA SpacersGlobus Medical, Inc. · 2016 · 2 generations on155descendants
- K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation · 2016 · 3 generations on79descendants
- K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation · 2017 · 4 generations on67descendants
- K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018 · 4 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −5 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −2 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −1 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| +3 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| +4 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| +4 | K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 19 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 22 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 19 | 1 |
| 2022 | 25 | 0 |
| 2023 | 25 | 0 |
| 2024 | 45 | 0 |
| 2025 | 39 | 0 |
| 2026 | 36 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K131669 | Perimeter Interbody Fusion DeviceSummary page 5…MAX, OVD (Interbody Cages) Predicates Primary Predicate PERIMETER® Interbody Fusion Device K131669 (S.E. 11/01/2013) Additional Predicates • CAPSTONE® Spinal System… | 2013 |
| * | K133650 | Capstone Spinal SystemSummary page 5…K131669 (S.E. 11/01/2013) Additional Predicates • CAPSTONE® Spinal System K133650 (S.E. 12/26/2013) • CLYDESDALE® Spinal System K132897 (S.E. 12/11/2013… | 2013 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5…• CAPSTONE® Spinal System K133650 (S.E. 12/26/2013) • CLYDESDALE® Spinal System K132897 (S.E. 12/11/2013) • CAPSTONE CONTROL K120368… | 2013 |
| * | K120368 | Capstone Control Spinal SystemSummary page 6…nal System K132897 (S.E. 12/11/2013) • CAPSTONE CONTROL K120368 (S.E. 04/09/2012) • LT CAGE® PEEK Lumbar Tapered Fusion Device… | 2012 |
| * | P970015 | Inter Fix Threaded Fusion DeviceSummary page 6…K120368 (S.E. 04/09/2012) • LT CAGE® PEEK Lumbar Tapered Fusion Device (P970015/R022 - Approved 09/10/2003 -Downclassed) • SOVEREIGN® Spinal System… | 1999 |
| * | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Summary page 6…(P970015/R022 - Approved 09/10/2003 -Downclassed) • SOVEREIGN® Spinal System K122037 ( S.E. 03/22/2013) • CoRoent® XLR Standalone System K100043 (… | 2013 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 6…System K122037 ( S.E. 03/22/2013) • CoRoent® XLR Standalone System K100043 (S.E. 06/13/2010) • BRIGADE® Hyperlordotic System K123045 (S.… | 2010 |
| * | K123045 | Brigade Standalone SystemSummary page 6…e System K100043 (S.E. 06/13/2010) • BRIGADE® Hyperlordotic System K123045 (S.E. 04/16/2013) • PYRAMID® +4 Anterior Lumbar Plate System… | 2013 |
| * | K071416 | Pyramid +4 Anterior Lumbar Spine Plate SystemSummary page 6…K123045 (S.E. 04/16/2013) • PYRAMID® +4 Anterior Lumbar Plate System K071416 (S.E. 11/01/2007) • ZPLATE II™ Anterior Fixation System K9914… | 2007 |
| * | K991460 | Modification to Zplate-Atl Anterior Fixation SystemSummary page 6…em K071416 (S.E. 11/01/2007) • ZPLATE II™ Anterior Fixation System K991460 (S.E. 05/19/1999 ). • Reference Predicate DIVERGENCE™ Anterio… | 1999 |
| † | K142450 | DIVERGENCE Anterior Cervical Fusion System | 2014 |
What descends from it? (228)
See all 22811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152277 | PIVOX (tm) Oblique Lateral Spinal System | 2015 | 190 |
| K162212 | Divergence-L Anterior/Oblique Lumbar Fusion System | 2017 | 57 |
| K162680 | SOVEREIGN® Spinal System | 2016 | 31 |
| K172328 | SOVEREIGN™ Spinal System | 2017 | 30 |
| K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | 2017 | 8 |
| K172083 | Idys™ ALIF System | 2017 | 7 |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 2017 | 5 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
| K211769 | OneLIF Intervertebral Body Replacement System | 2021 | 1 |
| K261408 | SABER-XA System | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 12 of the 155 ancestors have a recall of any class.
- Of its descendants, K152277 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 190 descendants of its own.
- 3 other devices also cite its predicate K131669.
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 DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody is indicated for interbody fusion in patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months…
Read the full statement (329 words)
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody is indicated for interbody fusion in patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion Interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Interbody cages with a lordosis of 18º or greater must be used with at least supplemental, anterior fixation.
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
When used together, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System components can be used only to treat patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150135
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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