510(k) · Cleared
ClearedEpicage Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 18, 2013 as substantially equivalent to K092901 (R Tree Innovations, 2010) after a 45-day review. Its family tree reaches back 2 generations to 1996. 1 of the 608 devices in its family, counting itself, has a Class I recall. 602 later devices descend from it.
- Decided
- Apr 18, 2013
- Review
- 45 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950002 (1996). 5 ancestors in all. 602 later devices descend from it, 3 citing it directly. 1 of the 608 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK092901 Epicage Interbody Fusion DeviceR Tree Innovations · 2010
- This deviceK130548 Epicage Interbody Fusion DeviceAlphatec Spine, Inc. · 2013
- Descendant · cites it directly · 596 of its ownK132601 Coroent Sterile Implants SystemNu Vasive, Incorporated · 2013
- Descendant · 2 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 483 of its ownK140659 Coroent Thoracolumbar ImplantsNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 480 of its ownK141896 Coroent SystemNu Vasive, Incorporated · 2014
Showing 5 of 602 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 602 · See all- K132601Coroent Sterile Implants SystemNu Vasive, Incorporated · 2013 · cites it directly596descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 2 generations on590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated · 2014 · 2 generations on483descendants
- K141896Coroent SystemNu Vasive, Incorporated · 2014 · 2 generations on480descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K092901 | Epicage Interbody Fusion Device | R Tree Innovations | 2010 | — |
| 0 (this device) | K130548 | Epicage Interbody Fusion Device | Alphatec Spine, Inc. | 2013 | — |
| +1 | K132601 | Coroent Sterile Implants System | Nu Vasive, Incorporated | 2013 | — |
| +2 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K140659 | Coroent Thoracolumbar Implants | Nu Vasive, Incorporated | 2014 | — |
| +2 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 21 | 0 |
| 2017 | 28 | 0 |
| 2018 | 31 | 0 |
| 2019 | 43 | 0 |
| 2020 | 64 | 0 |
| 2021 | 51 | 1 |
| 2022 | 61 | 0 |
| 2023 | 76 | 0 |
| 2024 | 83 | 0 |
| 2025 | 72 | 0 |
| 2026 | 59 | 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? (1)
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 |
|---|---|---|---|
| * | K092901 | Epicage Interbody Fusion DeviceSummary page 2…0548 2 of 2 Substantial Equivalence Claimed: The subject Epicage Interbody Fusion System is substantially equivalent to the predicate Epicage Interbody Fusion System (K092901) with the same intended use and technological characteristics. The subject system is manufactured from the same materials and man… | 2010 |
What descends from it? (602)
See all 6023 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K132601 (Nu Vasive, Incorporated, 2013) has gone furthest, with 596 descendants of its own.
- 2 other devices also cite its predicate K092901.
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. 2013, 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 Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is…
Read the full statement (125 words)
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Aiphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130548: Epicage 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/K130548
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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