510(k) · Cleared
ClearedSpine Innovation Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Innovation, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 14, 2016 as substantially equivalent to K123913 (Globus Medical, Inc., 2013) and 4 other predicates after a 55-day review. Its family tree reaches back 12 generations to 2001. 1 later device descends from it.
- Decided
- Jan 14, 2016
- Review
- 55 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K003155 (2001). 84 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK113478 Plif CageEisertech, LLC · 2012
- This deviceK153356 Spine Innovation Interbody SystemSpine Innovation, LLC · 2016
- Descendant · cites it directly · 0 of its ownK253266 Titanium Interbody SystemSpine Innovation, LLC · 2026
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK113478 Plif CageEisertech, LLC · 2012
- This deviceK153356 Spine Innovation Interbody SystemSpine Innovation, LLC · 2016
Most influential descendants
Showing 1 of 1 · See all- K253266Titanium Interbody SystemSpine Innovation, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −6 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −1 | K113478 | Plif Cage | Eisertech, LLC | 2012 | — |
| 0 (this device) | K153356 | Spine Innovation Interbody System | Spine Innovation, LLC | 2016 | — |
| +1 | K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2007 | 10 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K123913 | Latis SpacerSummary page 4…he competitive devices in all facets including: function, design, performance, material, and intended use. Primary Predicate Device: Globus Medical LATISTM Spacers (K123913) Additional Predicate Devices: Eisertech PLIF Cage (K113478) Synthes OPAL Spacer (K072791)… | 2013 |
| * | K113478 | Plif CageSummary page 4…ign, performance, material, and intended use. Primary Predicate Device: Globus Medical LATISTM Spacers (K123913) Additional Predicate Devices: Eisertech PLIF Cage (K113478) Synthes OPAL Spacer (K072791) Alphatec Epicage (K130548)… | 2012 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 4…cate Device: Globus Medical LATISTM Spacers (K123913) Additional Predicate Devices: Eisertech PLIF Cage (K113478) Synthes OPAL Spacer (K072791) Alphatec Epicage (K130548) SeaSpine PacificaTM (K082310) No referen… | 2007 |
| * | K130548 | Epicage Interbody Fusion DeviceSummary page 4…Additional Predicate Devices: Eisertech PLIF Cage (K113478) Synthes OPAL Spacer (K072791) Alphatec Epicage (K130548) SeaSpine PacificaTM (K082310) No reference devices were used in this submission. DEVICE DESCRIPT… | 2013 |
| * | K082310 | Hollywood, Pacifica, Redondo, VenturaSummary page 4…) Synthes OPAL Spacer (K072791) Alphatec Epicage (K130548) SeaSpine PacificaTM (K082310) No reference devices were used in this submission. DEVICE DESCRIPTION: The Spine Innovation Interbody System is an interbody… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253266 | Titanium Interbody System | 2026 | 0 |
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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 9 of the 84 ancestors have a recall of any class.
- Of its descendants, K253266 (Spine Innovation, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K123913.
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 Innovation Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These…
Read the full statement (127 words)
The Spine Innovation Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Spine Innovation Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Spine Innovation Interbody System.
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/K153356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153356: Spine Innovation 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/K153356
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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