510(k) · Cleared
ClearedEbi Ais Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MQP Spinal Vertebral Body Replacement Device
Cleared on May 16, 2002 as substantially equivalent to K841189 (Orthopedic Equipment Co., Inc., 1984) and 4 other predicates after a 59-day review. Its family tree reaches back 2 generations to 1984. 1 of the 1,628 devices in its family, counting itself, has a Class I recall. 1,622 later devices descend from it.
- Decided
- May 16, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K841189 (1984). 5 ancestors in all. 1,622 later devices descend from it, 2 citing it directly. 1 of the 1,628 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 1 generation backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- This deviceK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- Descendant · cites it directly · 1,621 of its ownK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- Descendant · cites it directly · 1,620 of its ownK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- Descendant · 2 generations on · 1,571 of its ownK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
- Descendant · 2 generations on · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- Descendant · 3 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
Showing 5 of 1,622 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 1,622 · See all- K040482Ebi Esl Spine Spacer SystemEbi, L.P. · 2004 · cites it directly1,621descendants
- K042268Ebi Cas Spine Spacer SystemEbi, L.P. · 2004 · cites it directly1,620descendants
- K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005 · 2 generations on1,571descendants
- K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · 2 generations on1,440descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,406descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −1 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| 0 (this device) | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| +1 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| +1 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| +2 | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) | Pioneer Surgical Technology | 2005 | — |
| +2 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| +3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 18 | 0 |
| 2009 | 11 | 0 |
| 2010 | 21 | 0 |
| 2011 | 43 | 0 |
| 2012 | 51 | 0 |
| 2013 | 62 | 0 |
| 2014 | 83 | 0 |
| 2015 | 83 | 0 |
| 2016 | 100 | 0 |
| 2017 | 124 | 0 |
| 2018 | 116 | 0 |
| 2019 | 117 | 0 |
| 2020 | 106 | 0 |
| 2021 | 105 | 1 |
| 2022 | 104 | 0 |
| 2023 | 139 | 0 |
| 2024 | 126 | 0 |
| 2025 | 101 | 0 |
| 2026 | 91 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K841189 | Oec/Rezaian Spinal FixatorSummary page 1…on Name/Code: - Spinal Vertebral Body Replacement Device/MQP Predicate or legally marketed devices that are substantially equivalent: = Rezaian Spinal Fixator by OEM (K841189) » Stackable Cage™ System by Depuy Acromed (K990148, K001340) = SynMesh™ System by Synthes (K003275) = Geo™ Structure by Interp… | 1984 |
| * | K990148 | Stackable Cage SystemSummary page 1…ice/MQP Predicate or legally marketed devices that are substantially equivalent: = Rezaian Spinal Fixator by OEM (K841189) » Stackable Cage™ System by Depuy Acromed (K990148, K001340) = SynMesh™ System by Synthes (K003275) = Geo™ Structure by Interpore Cross (K010530) Description of the device: The E… | 1999 |
| * | K001340 | Stackable Cage SystemSummary page 1…Predicate or legally marketed devices that are substantially equivalent: = Rezaian Spinal Fixator by OEM (K841189) » Stackable Cage™ System by Depuy Acromed (K990148, K001340) = SynMesh™ System by Synthes (K003275) = Geo™ Structure by Interpore Cross (K010530) Description of the device: The EBI AIS Sp… | 2000 |
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 1…hat are substantially equivalent: = Rezaian Spinal Fixator by OEM (K841189) » Stackable Cage™ System by Depuy Acromed (K990148, K001340) = SynMesh™ System by Synthes (K003275) = Geo™ Structure by Interpore Cross (K010530) Description of the device: The EBI AIS Spine System is a vertebral body replacem… | 2001 |
| * | K010530 | Geo StructureSummary page 1…pinal Fixator by OEM (K841189) » Stackable Cage™ System by Depuy Acromed (K990148, K001340) = SynMesh™ System by Synthes (K003275) = Geo™ Structure by Interpore Cross (K010530) Description of the device: The EBI AIS Spine System is a vertebral body replacement device comprised of an anatomically shaped… | 2001 |
What descends from it? (1,622)
See all 1,6222 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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K040482 (Ebi, L.P., 2004) has gone furthest, with 1,621 descendants of its own.
- 8 other devices also cite its predicate K841189.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time; The system must be used in conjunction with the EBI Omega 21 System or the EBI SpineLink 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/K020887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020887: Ebi Ais Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020887
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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