510(k) · Cleared
ClearedSpineolgy Peek Bullet Lumber 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 Sep 26, 2011 after an 87-day review. The FDA summary names its predicate without a number. 186 later devices descend from it.
- Decided
- Sep 26, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
186 later devices descend from it, 7 citing it directly.
- This deviceK111880 Spineolgy Peek Bullet Lumber Interbody Fusion DeviceSpineology, Inc. · 2011
- Descendant · cites it directly · 185 of its ownK113030 Spineology Peek Bullet Lumbar Interbody Fusion DeviceSpineology, Inc. · 2012
- Descendant · cites it directly · 184 of its ownK120293 Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012
- Descendant · cites it directly · 181 of its ownK130396 Rampart O and Rampart PSpineology, Inc. · 2013
- Descendant · cites it directly · 181 of its ownK123652 Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2013
- Descendant · cites it directly · 180 of its ownK131216 Rampart OSpineology, Inc. · 2013
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K113030Spineology Peek Bullet Lumbar Interbody Fusion DeviceSpineology, Inc. · 2012 · cites it directly185descendants
- K120293Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012 · cites it directly184descendants
- K130396Rampart O and Rampart PSpineology, Inc. · 2013 · cites it directly181descendants
- K123652Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2013 · cites it directly181descendants
- K131216Rampart OSpineology, Inc. · 2013 · cites it directly180descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111880 | Spineolgy Peek Bullet Lumber Interbody Fusion Device | Spineology, Inc. | 2011 | — |
| +1 | K113030 | Spineology Peek Bullet Lumbar Interbody Fusion Device | Spineology, Inc. | 2012 | — |
| +1 | K120293 | Spineology Peek Lumbar Interbody Fusion Drive | Spineology, Inc. | 2012 | — |
| +1 | K130396 | Rampart O and Rampart P | Spineology, Inc. | 2013 | — |
| +1 | K123652 | Spineology Peek Lumbar Interbody Fusion Device | Spineology, Inc. | 2013 | — |
| +1 | K131216 | Rampart O | Spineology, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 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 |
|---|---|---|---|
| * | — | 4CIS® PEEK PLIF Cage System from Solco, USA, Inc. Named without a submission number | |
| * | — | Capstone Spinal System, Medtronic Sofamor Danek Named without a submission number |
What descends from it? (186)
See all 1867 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113030 | Spineology Peek Bullet Lumbar Interbody Fusion Device | 2012 | 185 |
| K120293 | Spineology Peek Lumbar Interbody Fusion Drive | 2012 | 184 |
| K130396 | Rampart O and Rampart P | 2013 | 181 |
| K123652 | Spineology Peek Lumbar Interbody Fusion Device | 2013 | 181 |
| K131216 | Rampart O | 2013 | 180 |
| K163670 | Rampart One Lumbar Interbody Fusion Device | 2017 | 3 |
| K151020 | Rampart-T Interbody Fusion System | 2015 | 1 |
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, K113030 (Spineology, Inc., 2012) has gone furthest, with 185 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 Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device 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 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.…
Read the full statement (142 words)
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device 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 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 singly or in pairs via an open or a minimally invasive posterior or transfoaraminal approach.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with Supplemental fixation systems Ccared, by the FDA fior use in the lumbar spine.
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/K111880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111880: Spineolgy Peek Bullet Lumber Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111880
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