510(k) · Cleared
ClearedSpineology Peek Lumbar Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 13, 2011 after a 70-day review. The FDA summary names its predicate without a number. 185 later devices descend from it.
- Decided
- Jun 13, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
185 later devices descend from it, 2 citing it directly.
- This deviceK110933 Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2011
- Descendant · cites it directly · 184 of its ownK120293 Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012
- Descendant · 2 generations on · 181 of its ownK130396 Rampart O and Rampart PSpineology, Inc. · 2013
- Descendant · 2 generations on · 181 of its ownK123652 Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2013
- Descendant · 2 generations on · 180 of its ownK131216 Rampart OSpineology, Inc. · 2013
- Descendant · 2 generations on · 180 of its ownK121129 Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2012
Showing 5 of 185 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 185 · See all- K120293Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012 · cites it directly184descendants
- K130396Rampart O and Rampart PSpineology, Inc. · 2013 · 2 generations on181descendants
- K123652Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2013 · 2 generations on181descendants
- K131216Rampart OSpineology, Inc. · 2013 · 2 generations on180descendants
- K121129Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2012 · 2 generations on180descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110933 | Spineology Peek Lumbar Interbody Fusion Device | Spineology, Inc. | 2011 | — |
| +1 | K120293 | Spineology Peek Lumbar Interbody Fusion Drive | Spineology, Inc. | 2012 | — |
| +2 | K130396 | Rampart O and Rampart P | Spineology, Inc. | 2013 | — |
| +2 | K123652 | Spineology Peek Lumbar Interbody Fusion Device | Spineology, Inc. | 2013 | — |
| +2 | K131216 | Rampart O | Spineology, Inc. | 2013 | — |
| +2 | K121129 | Spineology Peek Lumbar Interbody Fusion Device | Spineology, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 10 | 0 |
| 2022 | 19 | 0 |
| 2023 | 22 | 0 |
| 2024 | 38 | 0 |
| 2025 | 31 | 0 |
| 2026 | 27 | 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? (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 |
|---|---|---|---|
| * | — | Pivotec Lumbar Interbody Fusion Device, Captiva Spine, Inc. Named without a submission number | |
| * | — | Capstone Spinal System, Medtronic Sofamor Danek Named without a submission number |
What descends from it? (185)
See all 1852 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?
- Of its descendants, K120293 (Spineology, Inc., 2012) has gone furthest, with 184 descendants of its own.
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. 2011, 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 Spineology PEEK Lumbar ihterbody Fusion Device is an intervertebral body fusion device indicated for interverfrbral body fuision 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 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…
Read the full statement (134 words)
The Spineology PEEK Lumbar ihterbody Fusion Device is an intervertebral body fusion
device indicated for interverfrbral body fuision 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 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.
These devices may be implanted via an open or a minimally invasive transforaminal
approach.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with
autograft to facilitate fusion and is intended for use with supplemental fixation systems
cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110933: Spineology Peek Lumbar Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110933
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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