510(k) · Cleared
Recalled · Class II · 2016Amendia Interbody Fusion Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 10, 2015 as substantially equivalent to K081614 (Interbody Innovations, Llp, 2008) and 2 other predicates after a 115-day review. Its family tree reaches back 15 generations to 1984. 226 later devices descend from it. It has been recalled once.
- Decided
- Sep 10, 2015
- Review
- 115 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 136 ancestors in all. 226 later devices descend from it, 6 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- This deviceK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015
- Descendant · cites it directly · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · cites it directly · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 2 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 3 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 4 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- This deviceK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015
Showing 5 of 226 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 226 · See all- K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · cites it directly169descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · cites it directly166descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 2 generations on129descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 3 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 4 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| 0 (this device) | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | — |
| +1 | K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +1 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +2 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +3 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 21 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 21 | 0 |
| 2021 | 19 | 0 |
| 2022 | 23 | 0 |
| 2023 | 31 | 0 |
| 2024 | 34 | 0 |
| 2025 | 36 | 0 |
| 2026 | 32 | 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 |
|---|---|---|---|
| * | K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesSummary page 4…080, Class II, Intervertebral Fusion Device with Bone Graft, Cervical Primary Predicate: Zeus Intervertebral Fusion Devices (K081614) Additional Predicates: NuVasive CoRoent System (K141665) Valeo C Spacer System,… | 2008 |
| * | K141665 | NuVasive CoRoent SystemSummary page 4…Graft, Cervical Primary Predicate: Zeus Intervertebral Fusion Devices (K081614) Additional Predicates: NuVasive CoRoent System (K141665) Valeo C Spacer System, Valeo II C IBF Device (K142264) Purpose of Submission: This 510(k) is… | 2015 |
| * | K142264 | Valeo C Spacer System, Valeo II C IBF DeviceSummary page 4…Devices (K081614) Additional Predicates: NuVasive CoRoent System (K141665) Valeo C Spacer System, Valeo II C IBF Device (K142264) Purpose of Submission: This 510(k) is intended to gain clearance for modifications to the Zeus Intervertebral Fusion System, in… | 2014 |
What descends from it? (226)
See all 2266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151310 | Amendia Interbody Fusion Devices | 2016 | 169 |
| K160924 | Amendia Interbody Fusion Devices | 2016 | 166 |
| K162496 | Foundation 3D Interbody | 2017 | 82 |
| K171046 | SeaSpine Cambria System | 2017 | 62 |
| K182920 | MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar… | 2019 | 9 |
| K211845 | Deploy Expandable Interbody System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2016 | Class II | Z-0827-2017 | Error in labeling | Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 19 of the 136 ancestors have a recall of any class.
- Of its descendants, K151310 (Amendia, Inc., 2016) has gone furthest, with 169 descendants of its own.
- 8 other devices also cite its predicate K081614.
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 Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the…
Read the full statement (202 words)
The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. 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. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151322: Amendia Interbody Fusion Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151322
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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