510(k) · Cleared
Recalled · Class II · 2018Spinal Jaxx Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuropro Spinaljaxx, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 29, 2016 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 5 other predicates after a 302-day review. Its family tree reaches back 15 generations to 2001. 1 of the 103 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jun 29, 2016
- Review
- 302 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 15 generations to K003155 (2001). 102 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 103 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 backK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- 1 generation backK140280 ForticoreNanovis, LLC · 2014
- This deviceK152501 Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc. · 2016
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 backK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- 1 generation backK140280 ForticoreNanovis, LLC · 2014
- This deviceK152501 Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc. · 2016
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
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 | K110442 | Nanovis Intervertebral Body Fusion System | Nanovis, LLC | 2011 | — |
| −1 | K140280 | Forticore | Nanovis, LLC | 2014 | — |
| 0 (this device) | K152501 | Spinal Jaxx Interbody Fusion Device | Neuropro Spinaljaxx, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 13 | 1 |
| 2009 | 8 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K102293 | Caliber SpacerSummary page 4…Product Code: MAX Regulatory Class II Panel Code 87 Predicate The primary predicate is the CALIBERTM Spacer (K102293). Additional Devices: predicate devices include the Rise Spacer (K113447), Brantigan Cage (AKA:… | 2011 |
| * | K113447 | Rise SpacerSummary page 4…Panel Code 87 Predicate The primary predicate is the CALIBERTM Spacer (K102293). Additional Devices: predicate devices include the Rise Spacer (K113447), Brantigan Cage (AKA: LT Cage & Jaguar Cage) (P960025), Ray Threaded Fusion Cage (P9… | 2012 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…pacer (K102293). Additional Devices: predicate devices include the Rise Spacer (K113447), Brantigan Cage (AKA: LT Cage & Jaguar Cage) (P960025), Ray Threaded Fusion Cage (P950019),Patriot Spacer (K072970) and the Nanovis Foricore device… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 4…e devices include the Rise Spacer (K113447), Brantigan Cage (AKA: LT Cage & Jaguar Cage) (P960025), Ray Threaded Fusion Cage (P950019),Patriot Spacer (K072970) and the Nanovis Foricore device (K140280) Purpose: The purpose of this submissio… | 1996 |
| * | K072970 | Patriot SpacersSummary page 4…e Spacer (K113447), Brantigan Cage (AKA: LT Cage & Jaguar Cage) (P960025), Ray Threaded Fusion Cage (P950019),Patriot Spacer (K072970) and the Nanovis Foricore device (K140280) Purpose: The purpose of this submission is clearance of the Spi… | 2008 |
| * | K140280 | ForticoreSummary page 4…T Cage & Jaguar Cage) (P960025), Ray Threaded Fusion Cage (P950019),Patriot Spacer (K072970) and the Nanovis Foricore device (K140280) Purpose: The purpose of this submission is clearance of the Spinal Jaxx Interbody Fusion Device as a new medical device that is… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 18, 2018 | Class II | Z-1350-2018 | Labeling Change Control | The implant size is incorrectly etched on the implant. The size listed on the box is correct. |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 10 of the 102 ancestors have a recall of any class; 1 has a Class I recall.
- 30 other devices also cite its predicate K102293.
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 Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2 – S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152501: Spinal Jaxx Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152501
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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