510(k) · Cleared
ClearedEbi Esl Peek-Optima 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 Jun 8, 2006 after a 56-day review. The FDA summary names its predicate without a number. 1 of the 526 devices in its family, counting itself, has a Class I recall. 525 later devices descend from it.
- Decided
- Jun 8, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
525 later devices descend from it, 2 citing it directly. 1 of the 526 devices in this family, counting this one, has a Class I recall.
- This deviceK061016 Ebi Esl Peek-Optima Spine SystemEbi, L.P. · 2006
- Descendant · cites it directly · 493 of its ownK063393 Small Stature SpacersBiomet Spine · 2007
- Descendant · 2 generations on · 492 of its ownK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- Descendant · 3 generations on · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- Descendant · 4 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · 4 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
Showing 5 of 525 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 525 · See all- K063393Small Stature SpacersBiomet Spine · 2007 · cites it directly493descendants
- K092336C-Thru Spinal SystemEbi, L.P. · 2009 · 2 generations on492descendants
- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · 3 generations on389descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 4 generations on331descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 4 generations on324descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061016 | Ebi Esl Peek-Optima Spine System | Ebi, L.P. | 2006 | — |
| +1 | K063393 | Small Stature Spacers | Biomet Spine | 2007 | — |
| +2 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| +3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| +4 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +4 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 15 | 0 |
| 2017 | 31 | 0 |
| 2018 | 21 | 0 |
| 2019 | 39 | 0 |
| 2020 | 36 | 0 |
| 2021 | 52 | 1 |
| 2022 | 48 | 0 |
| 2023 | 57 | 0 |
| 2024 | 62 | 0 |
| 2025 | 63 | 0 |
| 2026 | 61 | 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? (2)
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 |
|---|---|---|---|
| * | — | EBI® ESL® Spine Spacer System Named without a submission number | |
| * | — | Interpore Cross International PEEK CAS Named without a submission number |
What descends from it? (525)
See all 5252 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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K063393 (Biomet Spine, 2007) has gone furthest, with 493 descendants of its own.
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 ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., Ti to L5) for partial replacement of 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061016: Ebi Esl Peek-Optima 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/K061016
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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