510(k) Report

510(k) · Cleared

Cleared

Rampart-T Interbody Fusion System

K151020510(k) SpecialCleared Jul 22, 201597-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spineology, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jul 22, 2015 as substantially equivalent to K110933 (Spineology, Inc., 2011) and 3 other predicates after a 97-day review. Its family tree reaches back 6 generations to 2011. 1 later device descends from it.

Decided
Jul 22, 2015
Review
97 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K111880 (2011). 9 ancestors in all, the oldest K110933 (2011). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2012: 1 other ancestor2013: 1 other ancestor2017: 1 descendant clearedK111880 · Spineolgy Peek Bullet Lumber Interbody Fusion Device · Spineology, Inc. · 2011×2: 2 generations cleared close together, K113030 (2012), K120293 (2012) K123652 · Spineology Peek Lumbar Interbody Fusion Device · Spineology, Inc. · 2013K131216 · Rampart O · Spineology, Inc. · 2013K132053 · Rampart-O, Rampart-T · Spineology, Inc. · 20132010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant K132053 · Rampart-O, Rampart-T · Spineology, Inc. · 2013K131216 · Rampart O · Spineology, Inc. · 2013K123652 · Spineology Peek Lumbar Interbody Fusion Device · Spineology, Inc. · 2013K120293 · Spineology Peek Lumbar Interbody Fusion Drive · Spineology, Inc. · 2012K113030 · Spineology Peek Bullet Lumbar Interbody Fusion Device · Spineology, Inc. · 2012K111880 · Spineolgy Peek Bullet Lumber Interbody Fusion Device · Spineology, Inc. · 2011−50
  1. Root · 6 generations backK111880 Spineolgy Peek Bullet Lumber Interbody Fusion DeviceSpineology, Inc. · 2011
  2. 5 generations backK113030 Spineology Peek Bullet Lumbar Interbody Fusion DeviceSpineology, Inc. · 2012
  3. 4 generations backK120293 Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012
  4. 3 generations backK123652 Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc. · 2013
  5. 2 generations backK131216 Rampart OSpineology, Inc. · 2013
  6. 1 generation backK132053 Rampart-O, Rampart-TSpineology, Inc. · 2013
  7. This deviceK151020 Rampart-T Interbody Fusion SystemSpineology, Inc. · 2015
  8. Descendant · cites it directly · 0 of its ownK163409 Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K111880Spineolgy Peek Bullet Lumber Interbody Fusion DeviceSpineology, Inc.2011—
−5K113030Spineology Peek Bullet Lumbar Interbody Fusion DeviceSpineology, Inc.2012—
−4K120293Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc.2012—
−3K123652Spineology Peek Lumbar Interbody Fusion DeviceSpineology, Inc.2013—
−2K131216Rampart OSpineology, Inc.2013—
−1K132053Rampart-O, Rampart-TSpineology, Inc.2013—
0 (this device)K151020Rampart-T Interbody Fusion SystemSpineology, Inc.2015—
+1K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K151020, 2011–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K110933Spineology Peek Lumbar Interbody Fusion Device
Summary page 4
…umbar Classification Name: Intervertebral body fusion device (21 CFR §888.3080) Regulatory Class: Class II Product Code: MAX III. PREDICATE DEVICE Spineology PEEK LIFD K110933 (Primary Predicate), K111880, K132053, K113030 (Additional Predicates) IV. DEVICE DESCRIPTION The Spineology Rampart™-T Inte…
Spineology, Inc.2011—
*K111880Spineolgy Peek Bullet Lumber Interbody Fusion Device
Summary page 4
…tervertebral body fusion device (21 CFR §888.3080) Regulatory Class: Class II Product Code: MAX III. PREDICATE DEVICE Spineology PEEK LIFD K110933 (Primary Predicate), K111880, K132053, K113030 (Additional Predicates) IV. DEVICE DESCRIPTION The Spineology Rampart™-T Interbody Fusion implant is a tap…
Spineology, Inc.2011—
*K132053Rampart-O, Rampart-T
Summary page 4
…ral body fusion device (21 CFR §888.3080) Regulatory Class: Class II Product Code: MAX III. PREDICATE DEVICE Spineology PEEK LIFD K110933 (Primary Predicate), K111880, K132053, K113030 (Additional Predicates) IV. DEVICE DESCRIPTION The Spineology Rampart™-T Interbody Fusion implant is a tapered vers…
Spineology, Inc.2013—
*K113030Spineology Peek Bullet Lumbar Interbody Fusion Device
Summary page 4
…fusion device (21 CFR §888.3080) Regulatory Class: Class II Product Code: MAX III. PREDICATE DEVICE Spineology PEEK LIFD K110933 (Primary Predicate), K111880, K132053, K113030 (Additional Predicates) IV. DEVICE DESCRIPTION The Spineology Rampart™-T Interbody Fusion implant is a tapered version of th…
Spineology, Inc.2012—

Also cleared against K110933: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170

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 4 years and passes through 1 company; a new generation was cleared every 4 months on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K163409 (Spineology, Inc., 2017) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K110933.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

Rampart-T implants are intervertebral body fusion devices 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.

Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the FDA for 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.

Also cleared against K110933

1 other device cites the same predicate.

  • K120293Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 2012

More from Spineology, Inc.

54 FDA decisions under this applicant name. See the company

  • K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2025
  • K251943Spineology Navigation InstrumentsSpineology, Inc. · 2025
  • K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
  • K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
  • K213876Spineology Navigation InstrumentsSpineology, Inc. · 2022

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K151020 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151020: Rampart-T Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151020

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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