510(k) · Cleared
ClearedNovel Cervical Spinal Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 19, 2008 after a 93-day review. The FDA summary names no predicate by number. 1 of the 706 devices in its family, counting itself, has a Class I recall. 705 later devices descend from it.
- Decided
- Sep 19, 2008
- Review
- 93 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
705 later devices descend from it, 16 citing it directly. 1 of the 706 devices in this family, counting this one, has a Class I recall.
- This deviceK081730 Novel Cervical Spinal Spacer SystemAlphatec Spine, Inc. · 2008
- Descendant · cites it directly · 492 of its ownK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- Descendant · cites it directly · 458 of its ownK083118 Spinal Usa Anterior Cervical Interbody Fusion DeviceSpinal USA · 2009
- Descendant · 2 generations on · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- Descendant · 3 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
Showing 5 of 705 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 705 · See all- K092336C-Thru Spinal SystemEbi, L.P. · 2009 · cites it directly492descendants
- K083118Spinal Usa Anterior Cervical Interbody Fusion DeviceSpinal USA · 2009 · cites it directly458descendants
- K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · 2 generations on453descendants
- K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 3 generations on449descendants
- K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · 3 generations on444descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081730 | Novel Cervical Spinal Spacer System | Alphatec Spine, Inc. | 2008 | — |
| +1 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| +1 | K083118 | Spinal Usa Anterior Cervical Interbody Fusion Device | Spinal USA | 2009 | — |
| +2 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| +3 | K142050 | Nuvasive Coroent Small Contoured Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 17 | 0 |
| 2015 | 17 | 0 |
| 2016 | 19 | 0 |
| 2017 | 46 | 0 |
| 2018 | 38 | 0 |
| 2019 | 52 | 0 |
| 2020 | 61 | 0 |
| 2021 | 65 | 1 |
| 2022 | 65 | 0 |
| 2023 | 81 | 0 |
| 2024 | 75 | 0 |
| 2025 | 73 | 0 |
| 2026 | 70 | 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.
1 device in this family has a Class I recall. 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (705)
See all 70516 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092336 | C-Thru Spinal System | 2009 | 492 |
| K083118 | Spinal Usa Anterior Cervical Interbody Fusion Device | 2009 | 458 |
| K100698 | STCC | 2011 | 346 |
| K181435 | ATEC Cervical Spacer System | 2018 | 100 |
| K133784 | Vista-S Device, Associated Instrumentation | 2014 | 29 |
| K120396 | Reliance Cervical Ibf System | 2012 | 25 |
| K110915 | Cervical Cage | 2011 | 23 |
| K182477 | Cervical Spacer | 2019 | 15 |
| K110442 | Nanovis Intervertebral Body Fusion System | 2011 | 10 |
| K092794 | Transcorp Acif System | 2010 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K092336 (Ebi, L.P., 2009) has gone furthest, with 492 descendants of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
When used as a Vertebral Body Replacement When used as a vertebral body replacement, the Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial…
Read the full statement (307 words)
When used as a Vertebral Body Replacement
When used as a vertebral body replacement, the Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.
When used as a Lumbar Intervertebral Body Fusion
When used as a lumbar Intervertebral Body Fusion, the Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a Cervical Intervertebral Body Fusion
When used as a cervical intervertebral body fusion device, the Novel® Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to TI) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081730: Novel Cervical Spinal Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081730
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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