510(k) · Cleared
ClearedEsl Spinal System
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 Feb 4, 2010 as substantially equivalent to K040928 (Interpore Cross Intl., 2004) and 2 other predicates after a 167-day review. Its family tree reaches back 7 generations to 2001. 181 later devices descend from it.
- Decided
- Feb 4, 2010
- Review
- 167 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K010530 (2001). 13 ancestors in all, the oldest P950002 (1996). 181 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 6 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 5 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 4 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 3 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 2 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 1 generation backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- This deviceK092574 Esl Spinal SystemEbi, L.P. · 2010
- Descendant · cites it directly · 177 of its ownK110650 Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011
- Descendant · cites it directly · 174 of its ownK112014 Zyston Straight Spacer SystemBiomet Spine · 2011
- Descendant · cites it directly · 171 of its ownK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · 2 generations on · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 3 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 181 · See all- K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011 · cites it directly177descendants
- K112014Zyston Straight Spacer SystemBiomet Spine · 2011 · cites it directly174descendants
- K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly171descendants
- K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 2 generations on169descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 3 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −6 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −5 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −4 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −3 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −2 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −1 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| 0 (this device) | K092574 | Esl Spinal System | Ebi, L.P. | 2010 | — |
| +1 | K110650 | Zyston Arc Interbody Spacer | Biomet Spine (Aka Ebi, LLC) | 2011 | — |
| +1 | K112014 | Zyston Straight Spacer System | Biomet Spine | 2011 | — |
| +1 | K122989 | Biomet Lateral Spacer System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +2 | K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +3 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 13 | 0 |
| 2020 | 12 | 0 |
| 2021 | 14 | 0 |
| 2022 | 16 | 0 |
| 2023 | 22 | 0 |
| 2024 | 29 | 0 |
| 2025 | 29 | 0 |
| 2026 | 28 | 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 |
|---|---|---|---|
| * | K040928 | Expandable Peek VBR ImplantSummary page 1…ues of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406) and the ESL® Spinal System (K061016) has similar design features. Based upon the mechanical testing, ESLt Spinal Sys… | 2004 |
| * | K082406 | Expandable Peek-Optima ImplantSummary page 1…y or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406) and the ESL® Spinal System (K061016) has similar design features. Based upon the mechanical testing, ESLt Spinal System is subst… | 2009 |
| * | K061016 | Ebi Esl Peek-Optima Spine SystemSummary page 1…redicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406) and the ESL® Spinal System (K061016) has similar design features. Based upon the mechanical testing, ESLt Spinal System is substantially equivalent for its intended… | 2006 |
What descends from it? (181)
See all 1813 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K110650 (Biomet Spine (Aka Ebi, LLC), 2011) has gone furthest, with 177 descendants of its own.
- 9 other devices also cite its predicate K040928.
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. 2010, 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 ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 - 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…
Read the full statement (260 words)
The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 - 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® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal 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 period of time.
As an intervertebral body fusion device, the ESL® Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I 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 ESL® Spinal System 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. The ESL® Spinal System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092574: Esl Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092574
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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