510(k) · Cleared
ClearedArcadiusXP C Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on May 25, 2016 as substantially equivalent to K130274 (Elite Surgical Supplies (Pty), Ltd., 2013) after a 159-day review. Its family tree reaches back 11 generations to 1984. 7 later devices descend from it.
- Decided
- May 25, 2016
- Review
- 159 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K841189 (1984). 32 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK130274 Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd. · 2013
- This deviceK153629 ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 2 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · cites it directly · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK130274 Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd. · 2013
- This deviceK153629 ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · cites it directly6descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on5descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on2descendants
- K261279DeltaNEC Interbody SystemNexus Spine · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −1 | K130274 | Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System | Elite Surgical Supplies (Pty), Ltd. | 2013 | — |
| 0 (this device) | K153629 | ArcadiusXP C Spinal System | Aesculap Implant Systems, Inc. | 2016 | — |
| +1 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +2 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +2 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +1 | K261279 | DeltaNEC Interbody System | Nexus Spine | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K130274 | Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemSummary page 6…es, and the device is therefore found to be substantially equivalent. PRIMARY PREDICATE Elite Surgical Supplies: Biolign Stand Alone Cervical Cage (STACC) ACIF System – K130274 REFERENCE DEVICES Centinel Spine: Stalif C® – K150053 / K142079 Aesculap Implant Systems: SIBD XP Spinal System – K111122 | 2013 |
| † | K150053 | STALIF C; STALIF C-Ti | 2015 |
| † | K142079 | Stalif Cti, Stalif C | 2014 |
| † | K111122 | Aesculap Sibd XP Spinal System | 2011 |
What descends from it? (7)
2 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 32 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 32 ancestors have a recall of any class.
- Of its descendants, K231763 (Nexus Spine, LLC, 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K130274.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/Tl disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc…
Read the full statement (113 words)
The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/Tl disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies) using autograft bone.
Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153629: ArcadiusXP C Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153629
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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