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 May 19, 2017 as substantially equivalent to K133577 (Medtronic Sofamor Danek USA, Inc., 2014) and 2 other predicates after a 284-day review. Its family tree reaches back 16 generations to 2001. 57 later devices descend from it.
- Decided
- May 19, 2017
- Review
- 284 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K003155 (2001). 158 ancestors in all, the oldest K792352 (1979). 57 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 2 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 1 generation backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK162212 Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2017
- Descendant · cites it directly · 30 of its ownK172328 SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017
- Descendant · cites it directly · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
- Descendant · 2 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · 4 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 6 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 5 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 3 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 2 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 1 generation backK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK162212 Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2017
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2017 · cites it directly30descendants
- K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · cites it directly25descendants
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on21descendants
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 3 generations on20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −6 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −5 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −3 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −2 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −1 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K162212 | Divergence-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +1 | K172328 | SOVEREIGN™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +1 | K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 | — |
| +2 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +4 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 17 | 0 |
| 2025 | 11 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K133577 | Clydesdale (R) Spinal SystemSummary page 4…KWQ (Plates and Screws) Predicates Primary Predicate CLYDESDALE® Spinal System K133577 (S.E. 09/26/2014 – Primary Predicate) DIVERGENCE-L™ Anterior/Oblique Fusion System… | 2014 |
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 4…K133577 (S.E. 09/26/2014 – Primary Predicate) DIVERGENCE-L™ Anterior/Oblique Fusion System K150135 (S.E. 06/11/2015 – Secondary Predicate) CAPSTONE®/CLYDESDALE® Spinal System… | 2015 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 4…K150135 (S.E. 06/11/2015 – Secondary Predicate) CAPSTONE®/CLYDESDALE® Spinal System K151128 (S.E. 08/06/2015 – Secondary Predicate) The predicates have not been subject to a design related rec… | 2015 |
What descends from it? (57)
See all 573 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 16 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 158 ancestors have a recall of any class.
- Of its descendants, K172328 (Medtronic Sofamor Danek USA, Inc., 2017) has gone furthest, with 30 descendants of its own.
- 5 other devices also cite its predicate K133577.
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. 2017, 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 device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have…
Read the full statement (298 words)
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody device is intended for interbody fusion in
skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine.
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in 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. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Interbody
device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should
have had six months of non-operative treatment. The DIVERGENCE-L™ Interbody device is intended to be used with
autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants may be
implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.
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.
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/K162212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162212: 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/K162212
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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