510(k) · Cleared
ClearedRampart One Lumbar Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 8, 2017 as substantially equivalent to K153082 (Spineology, Inc., 2016) and 5 other predicates after a 132-day review. Its family tree reaches back 19 generations to 1984. 3 later devices descend from it.
- Decided
- May 8, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K841189 (1984). 175 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- This deviceK163670 Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK180002 Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK191091 Rampart One Lumbar Interbody Fusion SystemSpineology, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK192047 Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc. · 2019
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160906 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody…Spineology, Inc. · 2016
- This deviceK163670 Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018 · cites it directly2descendants
- K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc. · 2019 · 2 generations on1descendant
- K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −1 | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion… | Spineology, Inc. | 2016 | — |
| 0 (this device) | K163670 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | 2017 | — |
| +1 | K180002 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | 2018 | — |
| +2 | K191091 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | 2019 | — |
| +3 | K192047 | Rampart™ One Lumbar Interbody Fusion System | Spineology, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 23 | 0 |
| 2009 | 17 | 0 |
| 2010 | 8 | 0 |
| 2011 | 12 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K153082 | Rampart A Lumbar Interbody Fusion DeviceSummary page 4…OVD Regulatory Class: Class II Regulation Number: 21 CFR 888.3080 Panel: Orthopedic Predicate Devices Primary: K153082 Rampart A Lumbar Interbody Fusion Device (Spineology Inc.) Additional: K111880 Rampart P Lumbar Interbody Fusion D… | 2016 |
| * | K111880 | Spineolgy Peek Bullet Lumber Interbody Fusion DeviceSummary page 4…888.3080 Panel: Orthopedic Predicate Devices Primary: K153082 Rampart A Lumbar Interbody Fusion Device (Spineology Inc.) Additional: K111880 Rampart P Lumbar Interbody Fusion Device (Spineology Inc.) K160906 Rampart A, O, T Lumbar Interbody Fu… | 2011 |
| * | K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Summary page 4…2 Rampart A Lumbar Interbody Fusion Device (Spineology Inc.) Additional: K111880 Rampart P Lumbar Interbody Fusion Device (Spineology Inc.) K160906 Rampart A, O, T Lumbar Interbody Fusion Devices (Spineology Inc.) K150321 EVOS Lumbar Interbody Fusion… | 2016 |
| * | K150321 | EVOS Lumbar Interbody SystemSummary page 4…Rampart P Lumbar Interbody Fusion Device (Spineology Inc.) K160906 Rampart A, O, T Lumbar Interbody Fusion Devices (Spineology Inc.) K150321 EVOS Lumbar Interbody Fusion Device (Cutting Edge Spine, LLC) K072253 SynFix LR (Synthes Spine)… | 2015 |
| * | K072253 | Synfix-LR SpacerSummary page 4…mpart A, O, T Lumbar Interbody Fusion Devices (Spineology Inc.) K150321 EVOS Lumbar Interbody Fusion Device (Cutting Edge Spine, LLC) K072253 SynFix LR (Synthes Spine) K163543 Durango Stand-Alone ALIF System (Biomet Spine) I. Purpose The… | 2007 |
| * | K163543 | Biomet Fusion System Cleared while this submission was under review Summary page 4…gy Inc.) K150321 EVOS Lumbar Interbody Fusion Device (Cutting Edge Spine, LLC) K072253 SynFix LR (Synthes Spine) K163543 Durango Stand-Alone ALIF System (Biomet Spine) I. Purpose The purpose of this premarket notification is to obtain ini… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180002 | Rampart One Lumbar Interbody Fusion Device | 2018 | 2 |
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 33 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 17 of the 175 ancestors have a recall of any class.
- Of its descendants, K180002 (Spineology, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K153082.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The standard and oblique Rampart One devices are integrated 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.…
Read the full statement (124 words)
The standard and oblique Rampart One devices are integrated 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 non-operative treatment.
The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixation systems cleared by FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163670: Rampart One Lumbar Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163670
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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