510(k) · Cleared
Recalled · 2009Novel Spinal Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on May 21, 2008 after a 70-day review. The FDA summary names no predicate by number. 1 of the 799 devices in its family, counting itself, has a Class I recall. 798 later devices descend from it. It has been recalled once.
- Decided
- May 21, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 0
798 later devices descend from it, 11 citing it directly. 1 of the 799 devices in this family, counting this one, has a Class I recall.
- This deviceK080699 Novel Spinal Spacer SystemAlphatec Spine, Inc. · 2008
- Descendant · cites it directly · 589 of its ownK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 570 of its ownK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 527 of its ownK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 798 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 798 · See all- K110843Aleutian Spacer SystemK2m, Inc. · 2011 · cites it directly589descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K130699Aleutian Spinal SystemK2m, Inc. · 2013 · 2 generations on570descendants
- K133614Aleutian Ibf SystemK2m, Inc. · 2014 · 2 generations on527descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080699 | Novel Spinal Spacer System | Alphatec Spine, Inc. | 2008 | — |
| +1 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| +2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 19 | 0 |
| 2016 | 30 | 0 |
| 2017 | 54 | 0 |
| 2018 | 56 | 0 |
| 2019 | 64 | 0 |
| 2020 | 81 | 0 |
| 2021 | 71 | 1 |
| 2022 | 74 | 0 |
| 2023 | 94 | 0 |
| 2024 | 93 | 0 |
| 2025 | 78 | 0 |
| 2026 | 65 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (798)
See all 79811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110843 | Aleutian Spacer System | 2011 | 589 |
| K141665 | NuVasive CoRoent System | 2015 | 588 |
| K090425 | Guided Lateral Interbody Fusion (Glif) System | 2009 | 319 |
| K143740 | Battalion Universal Spacer System | 2015 | 247 |
| K112014 | Zyston Straight Spacer System | 2011 | 174 |
| K180480 | ATEC Universal Spacer System | 2018 | 113 |
| K160646 | XYcor® Expandable Spinal Spacer System | 2016 | 41 |
| K162986 | SPIRA Open Matrix ALIF | 2017 | 11 |
| K180724 | SPIRA Open Matrix LLIF | 2018 | 10 |
| K133721 | Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif… | 2014 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2009 | Not classified | Z-0190-2010 | Process control | Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant. |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K110843 (K2m, Inc., 2011) has gone furthest, with 589 descendants of its own.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
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…
Read the full statement (179 words)
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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080699: Novel 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/K080699
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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