510(k) · Cleared
ClearedRampart O
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 May 30, 2013 as substantially equivalent to K111880 (Spineology, Inc., 2011) and 4 other predicates after a 30-day review. Its family tree reaches back 4 generations to 2011. 180 later devices descend from it.
- Decided
- May 30, 2013
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K111880 (2011). 6 ancestors in all, the oldest K110933 (2011). 180 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK111880 Spineolgy Peek Bullet Lumber Interbody Fusion DeviceSpineology, Inc. · 2011
- 3 generations backK113030 Spineology Peek Bullet Lumbar Interbody Fusion DeviceSpineology, Inc. · 2012
- 2 generations backK120293 Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012
- 1 generation backK123652 Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2013
- This deviceK131216 Rampart OSpineology, Inc. · 2013
- Descendant · cites it directly · 179 of its ownK132053 Rampart-O, Rampart-TSpineology, Inc. · 2013
- Descendant · 2 generations on · 144 of its ownK171031 CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017
- Descendant · 3 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · 4 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 56 of its ownK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 180 · See all- K132053Rampart-O, Rampart-TSpineology, Inc. · 2013 · cites it directly179descendants
- K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017 · 2 generations on144descendants
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 3 generations on97descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 4 generations on84descendants
- K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K111880 | Spineolgy Peek Bullet Lumber Interbody Fusion Device | Spineology, Inc. | 2011 | — |
| −3 | K113030 | Spineology Peek Bullet Lumbar Interbody Fusion Device | Spineology, Inc. | 2012 | — |
| −2 | K120293 | Spineology Peek Lumbar Interbody Fusion Drive | Spineology, Inc. | 2012 | — |
| −1 | K123652 | Spineology Peek Lumbar Interbody Fusion Device | Spineology, Inc. | 2013 | — |
| 0 (this device) | K131216 | Rampart O | Spineology, Inc. | 2013 | — |
| +1 | K132053 | Rampart-O, Rampart-T | Spineology, Inc. | 2013 | — |
| +2 | K171031 | CRESCENT™ Spinal System | Medtronic Sofamor Danek | 2017 | — |
| +3 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +4 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +3 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K111880 | Spineolgy Peek Bullet Lumber Interbody Fusion Device | 2011 |
| * | K113030 | Spineology Peek Bullet Lumbar Interbody Fusion DeviceSummary page 1…cal Device, Product Code MAX, 21 CRF 888.3080 Predicate Device(s): Spineology PEEK Lumbar Interbody Fusion Devices (K I 11880, KI 113030, K 120293, K 123652 and K 130396) Rampart T M 0 devices are designed for use with autograft as an… | 2012 |
| * | K120293 | Spineology Peek Lumbar Interbody Fusion DriveSummary page 1…ce, Product Code MAX, 21 CRF 888.3080 Predicate Device(s): Spineology PEEK Lumbar Interbody Fusion Devices (K I 11880, KI 113030, K 120293, K 123652 and K 130396) Rampart T M 0 devices are designed for use with autograft as an adjunct to… | 2012 |
| * | K123652 | Spineology Peek Lumbar Interbody Fusion DeviceSummary page 1…t Code MAX, 21 CRF 888.3080 Predicate Device(s): Spineology PEEK Lumbar Interbody Fusion Devices (K I 11880, KI 113030, K 120293, K 123652 and K 130396) Rampart T M 0 devices are designed for use with autograft as an adjunct to… | 2013 |
| * | K130396 | Rampart O and Rampart PSummary page 1…1 CRF 888.3080 Predicate Device(s): Spineology PEEK Lumbar Interbody Fusion Devices (K I 11880, KI 113030, K 120293, K 123652 and K 130396) Rampart T M 0 devices are designed for use with autograft as an adjunct to… | 2013 |
What descends from it? (180)
See all 1802 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 2 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K132053 (Spineology, Inc., 2013) has gone furthest, with 179 descendants of its own.
- 6 other devices also cite its predicate K111880.
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. 2013, 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?
Rampart™ 0 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…
Read the full statement (132 words)
Rampart™ 0 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 transforaminal approach.
Rampart™ 0 is designed for use with autograft as an adjunct to 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/K131216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131216: Rampart O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131216
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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