510(k) · Cleared
ClearedExpandable Peek-Optima Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 14, 2009 as substantially equivalent to K081636 (Biomet Spine, 2008) after a 146-day review. Its family tree reaches back 6 generations to 2001. 1 of the 539 devices in its family, counting itself, has a Class I recall. 527 later devices descend from it.
- Decided
- Jan 14, 2009
- Review
- 146 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010530 (2001). 11 ancestors in all, the oldest P950002 (1996). 527 later devices descend from it, 7 citing it directly. 1 of the 539 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 2 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 1 generation backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- This deviceK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- Descendant · cites it directly · 492 of its ownK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- Descendant · 2 generations on · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · 3 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 3 generations on · 281 of its ownK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
Showing 5 of 527 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 527 · See all- K092336C-Thru Spinal SystemEbi, L.P. · 2009 · cites it directly492descendants
- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · 2 generations on389descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 3 generations on331descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 3 generations on324descendants
- K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc. · 2013 · 3 generations on281descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −2 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −1 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| 0 (this device) | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| +1 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| +2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| +3 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +3 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +3 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 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 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 |
|---|---|---|---|
| * | K081636 | Peek-Optima Alif SpacerSummary page 1…es of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the PEEK-OPTIMA® ALIF Spacer (K081636) and the Expandable PEEK-OPTIMA® Implant has similar design features. Based upon the mechanical testing, the Expandable PEEK-OPTI… | 2008 |
What descends from it? (527)
See all 5277 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092336 | C-Thru Spinal System | 2009 | 492 |
| K092574 | Esl Spinal System | 2010 | 181 |
| K091381 | Ibex Spinal System | 2009 | 181 |
| K110650 | Zyston Arc Interbody Spacer | 2011 | 177 |
| K112014 | Zyston Straight Spacer System | 2011 | 174 |
| K122989 | Biomet Lateral Spacer System | 2012 | 171 |
| K120557 | Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35 | 2012 | 1 |
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 8 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K092336 (Ebi, L.P., 2009) has gone furthest, with 492 descendants of its own.
- 3 other devices also cite its predicate K081636.
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. 2009, 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 Expandable PEEK-OPTIMA® Implant is indicated for vertebral body replacement. and intervertebral fusion. When used for vertebral body replacement, The Expandable PEEK-OPTIMA® Implant is indicated for use in the thoracolumbar spine (i.e., TI 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…
Read the full statement (229 words)
The Expandable PEEK-OPTIMA® Implant is indicated for vertebral body replacement. and intervertebral fusion. When used for vertebral body replacement, The Expandable PEEK-OPTIMA® Implant is indicated for use in the thoracolumbar spine (i.e., TI 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 Expandable PEEK-OPTIMA® Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK-OPTIMA® Implant 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.
As an intervertebral body fusion device, the Expandable PEEK-OPTIMA® Implant is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Expandable PEEK-OPTIMA® Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082406: Expandable Peek-Optima Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082406
Report an extraction error
Are you the manufacturer?
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