510(k) · Cleared
ClearedInterbody Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eisertech, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 23, 2015 as substantially equivalent to K113478 (Eisertech, LLC, 2012) and 2 other predicates after a 436-day review. Its family tree reaches back 12 generations to 2001. 235 later devices descend from it.
- Decided
- Apr 23, 2015
- Review
- 436 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K003155 (2001). 63 ancestors in all, the oldest K841189 (1984). 235 later devices descend from it, 4 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 deviceK140348 Interbody CageEisertech, LLC · 2015
- Descendant · cites it directly · 224 of its ownK163506 Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or…Vertera, Inc. · 2017
- Descendant · 2 generations on · 160 of its ownK173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 159 of its ownK181860 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 157 of its ownK193541 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
- Descendant · 2 generations on · 156 of its ownK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
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 deviceK140348 Interbody CageEisertech, LLC · 2015
Showing 5 of 235 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 235 · See all- K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc. · 2017 · cites it directly224descendants
- K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017 · 2 generations on160descendants
- K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018 · cites it directly159descendants
- K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020 · 2 generations on157descendants
- K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2020 · 2 generations on156descendants
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) | K140348 | Interbody Cage | Eisertech, LLC | 2015 | — |
| +1 | K163506 | Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique)… | Vertera, Inc. | 2017 | — |
| +2 | K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2018 | — |
| +2 | K193541 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020 | — |
| +2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
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 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 16 | 0 |
| 2021 | 17 | 0 |
| 2022 | 27 | 0 |
| 2023 | 35 | 0 |
| 2024 | 48 | 0 |
| 2025 | 42 | 0 |
| 2026 | 39 | 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 |
|---|---|---|---|
| * | K113478 | Plif CageSummary page 5…). The specific grades of PEEK used may be either Zeniva ZA-500 (Solvay) or Vestakeep 4iR (Evonik). Predicate Devices Primary Predicate: Eisertech, LLC PLIF Cage (k113478) Additional Predicates: Titan Spine Endoskeleton (k083714) Alphatec GLIF Cage (k090425) Reference Predicates: K7… | 2012 |
| * | K083714 | Endoskeleton TT Interbody Fusion Device (Ibd)Summary page 5…Solvay) or Vestakeep 4iR (Evonik). Predicate Devices Primary Predicate: Eisertech, LLC PLIF Cage (k113478) Additional Predicates: Titan Spine Endoskeleton (k083714) Alphatec GLIF Cage (k090425) Reference Predicates: K7, LLC - K133126 - Lumbar Cages Cogent Spine - K132738 - Lumba… | 2009 |
| * | K090425 | Guided Lateral Interbody Fusion (Glif) SystemSummary page 5…. Predicate Devices Primary Predicate: Eisertech, LLC PLIF Cage (k113478) Additional Predicates: Titan Spine Endoskeleton (k083714) Alphatec GLIF Cage (k090425) Reference Predicates: K7, LLC - K133126 - Lumbar Cages Cogent Spine - K132738 - Lumbar Cage DiFusion - K123969 - A… | 2009 |
| † | K133126 | K7 Lumbar Spacers | 2013 |
| † | K132738 | Cogent Med-Lif | 2014 |
| † | K123969 | Xiphos | 2013 |
| † | K133340 | Spineworks Anterior Lumbar Device | 2014 |
What descends from it? (235)
See all 2354 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163506 | Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar… | 2017 | 224 |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | 2018 | 159 |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX… | 2018 | 12 |
| K183407 | Triton Cage | 2019 | 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 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 8 of the 63 ancestors have a recall of any class.
- Of its descendants, K163506 (Vertera, Inc., 2017) has gone furthest, with 224 descendants of its own.
- 7 other devices also cite its predicate K113478.
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 Interbody Cage is indicated for use with autogenous bone graft 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 I 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140348: Interbody Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140348
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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