510(k) · Cleared
ClearedPlif 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 Mar 5, 2012 as substantially equivalent to K071983 (Aesculap Implant Systems, Inc., 2008) and 2 other predicates after a 103-day review. Its family tree reaches back 11 generations to 2001. 269 later devices descend from it.
- Decided
- Mar 5, 2012
- Review
- 103 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K003155 (2001). 52 ancestors in all, the oldest K841189 (1984). 269 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations between
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK113478 Plif CageEisertech, LLC · 2012
- Descendant · cites it directly · 235 of its ownK140348 Interbody CageEisertech, LLC · 2015
- Descendant · 2 generations on · 224 of its ownK163506 Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or…Vertera, Inc. · 2017
- Descendant · 3 generations on · 160 of its ownK173153 Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 159 of its ownK181860 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018
- Descendant · 3 generations on · 157 of its ownK193541 NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020
Show all 11 generations
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations backK012254 VBROsteotech, Inc. · 2001
- 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK113478 Plif CageEisertech, LLC · 2012
Showing 5 of 269 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 269 · See all- K140348Interbody CageEisertech, LLC · 2015 · cites it directly235descendants
- K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc. · 2017 · 2 generations on224descendants
- K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated · 2017 · 3 generations on160descendants
- K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2018 · 2 generations on159descendants
- K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated · 2020 · 3 generations on157descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −10 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −9 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −5 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −1 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| 0 (this device) | K113478 | Plif Cage | Eisertech, LLC | 2012 | — |
| +1 | K140348 | Interbody Cage | Eisertech, LLC | 2015 | — |
| +2 | K163506 | Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique)… | Vertera, Inc. | 2017 | — |
| +3 | K173153 | Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2018 | — |
| +3 | K193541 | NuVasive Cohere Thoracolumbar Interbody 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 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 10 | 0 |
| 2020 | 19 | 0 |
| 2021 | 20 | 0 |
| 2022 | 29 | 0 |
| 2023 | 38 | 0 |
| 2024 | 50 | 0 |
| 2025 | 43 | 0 |
| 2026 | 40 | 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 |
|---|---|---|---|
| * | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceSummary page 3…vices Mechanical testing has demonstrated that the PLIF Cage is equivalent in function to the following predicate devices: Aesculap ProSpace PEEK Spinal Implant System (k071983), the Medtronic Sofamor Danek CAPSTONE Spinal System (k073291), and the Synthes Oracle and Opal Spacer (k072791). Each device per… | 2008 |
| * | K073291 | Capstone Spinal SystemSummary page 3…s equivalent in function to the following predicate devices: Aesculap ProSpace PEEK Spinal Implant System (k071983), the Medtronic Sofamor Danek CAPSTONE Spinal System (k073291), and the Synthes Oracle and Opal Spacer (k072791). Each device performs the same mechanical function, holding open the disc spac… | 2008 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 1…sculap ProSpace PEEK Spinal Implant System (k<071983), the Medtronic Sofamor Danek CAPSTONE Spinal System (k<073291), and the Synthes Oracle and Opal Spacer (k072791). Device Description The PLIF Cage is a hollow, generally rectangular box made of polyetheretherketone (PEEK)… | 2007 |
What descends from it? (269)
See all 2698 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140348 | Interbody Cage | 2015 | 235 |
| K132738 | Cogent Med-Lif | 2014 | 13 |
| K131178 | Idys Lif Cages | 2013 | 11 |
| K171914 | Cortina™ Lumbar Cage System | 2017 | 2 |
| K160699 | VIRTU Lumbar Spacer System | 2016 | 2 |
| K153356 | Spine Innovation Interbody System | 2016 | 1 |
| K162693 | VertebraLINK Fusion Platform | 2017 | 0 |
| K152200 | SurgTech Interbody System | 2016 | 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 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 6 of the 52 ancestors have a recall of any class.
- Of its descendants, K140348 (Eisertech, LLC, 2015) has gone furthest, with 235 descendants of its own.
- 11 other devices also cite its predicate K071983.
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. 2012, 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 PLIF Cage is indicated for use with autogenous bone graft in patients with, degenerative disc disease (ODD) at one or two contiguous levels from L2 to Si. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DOD 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/K113478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113478: Plif Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113478
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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