510(k) · Cleared
ClearedPIVOX (tm) Oblique Lateral Spinal 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 Nov 13, 2015 as substantially equivalent to K150135 (Medtronic Sofamor Danek USA, Inc., 2015) and 6 other predicates after a 93-day review. Its family tree reaches back 16 generations to 2001. 1 of the 383 devices in its family, counting itself, has a Class I recall. 190 later devices descend from it.
- Decided
- Nov 13, 2015
- Review
- 93 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K003155 (2001). 192 ancestors in all, the oldest K792352 (1979). 190 later devices descend from it, 4 citing it directly. 1 of the 383 devices in this family, counting this one, has a Class I recall.
- 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 deviceK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 79 of its ownK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- Descendant · 3 generations on · 67 of its ownK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- Descendant · 3 generations on · 63 of its ownK181079 SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · 3 generations on · 60 of its ownK200879 SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2020
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 deviceK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 190 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 190 · See all- K161379ELSA SpacersGlobus Medical, Inc. · 2016 · cites it directly155descendants
- K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation · 2016 · 2 generations on79descendants
- K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation · 2017 · 3 generations on67descendants
- K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018 · 3 generations on63descendants
- K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2020 · 3 generations on60descendants
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) | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| +2 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| +3 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| +3 | K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018 | — |
| +3 | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 | — |
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 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 16 | 0 |
| 2004 | 31 | 0 |
| 2005 | 16 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 23 | 0 |
| 2009 | 9 | 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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 1 |
| 2022 | 21 | 0 |
| 2023 | 25 | 0 |
| 2024 | 38 | 0 |
| 2025 | 36 | 0 |
| 2026 | 34 | 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? (7)
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 |
|---|---|---|---|
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 4…Primary Predicate • DIVERGENCE™-L™ Anterior Oblique Lumbar Fusion System (K150135 - S.E. 06/11/2015) Additional Predicates • CLYDESDALE® Spinal Sy… | 2015 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 4…- S.E. 06/11/2015) Additional Predicates • CLYDESDALE® Spinal System K151128 (S.E. 08/06/2015) • CLYDESDALE® Spinal System K133577 (S.E.… | 2015 |
| * | K133577 | Clydesdale (R) Spinal SystemSummary page 4…nal System K151128 (S.E. 08/06/2015) • CLYDESDALE® Spinal System K133577 (S.E. 09/26/2014) K152277… | 2014 |
| * | K131669 | Perimeter Interbody Fusion DeviceSummary page 5…Page 2 of 6 • PERIMETER® Interbody Fusion Device K131669 (S.E. 11/01/2013) • PYRAMID® +4 Anterior Lumbar Plate System… | 2013 |
| * | K071416 | Pyramid +4 Anterior Lumbar Spine Plate SystemSummary page 5…K131669 (S.E. 11/01/2013) • PYRAMID® +4 Anterior Lumbar Plate System K071416 (S.E. 11/01/2007) • ZPLATE II™ Anterior Fixation System K9… | 2007 |
| * | K991460 | Modification to Zplate-Atl Anterior Fixation SystemSummary page 5…K071416 (S.E. 11/01/2007) • ZPLATE II™ Anterior Fixation System K991460 (S.E. 05/19/1999). • CD HORIZON® Spinal System K091442 (S.… | 1999 |
| * | K091442 | CD Horizon Spinal SystemSummary page 5…System K991460 (S.E. 05/19/1999). • CD HORIZON® Spinal System K091442 (S.E. 07/15/2009) III. Product Description The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plate… | 2009 |
What descends from it? (190)
See all 1904 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 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.
- 17 of the 192 ancestors have a recall of any class.
- Of its descendants, K161379 (Globus Medical, Inc., 2016) has gone furthest, with 155 descendants of its own.
- 10 other devices also cite its predicate K150135.
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 PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD…
Read the full statement (337 words)
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. 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 PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.
The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be 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 PIVOX™ Oblique Lateral Spinal System components can be used to treat 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.
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/K152277 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152277: PIVOX (tm) Oblique Lateral Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152277
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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