510(k) · Cleared
ClearedZuma, Model 55-XXXX/56-XXXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 22, 2008 after an 82-day review. The FDA summary names no predicate by number. 171 later devices descend from it.
- Decided
- Dec 22, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 0
171 later devices descend from it, 3 citing it directly.
- This deviceK082926 Zuma, Model 55-XXXX/56-XXXXSeaspine, Inc. · 2008
- Descendant · cites it directly · 168 of its ownK092521 ZUMA-CSeaspine, Inc. · 2010
- Descendant · 2 generations on · 131 of its ownK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- Descendant · 3 generations on · 99 of its ownK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · 4 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K092521ZUMA-CSeaspine, Inc. · 2010 · cites it directly168descendants
- K102547Coroent Interlock SystemNuvasive, Inc. · 2011 · 2 generations on131descendants
- K142299CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014 · 3 generations on99descendants
- K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · 3 generations on94descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 4 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082926 | Zuma, Model 55-XXXX/56-XXXX | Seaspine, Inc. | 2008 | — |
| +1 | K092521 | ZUMA-C | Seaspine, Inc. | 2010 | — |
| +2 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| +3 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +4 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 17 | 0 |
| 2023 | 25 | 0 |
| 2024 | 28 | 0 |
| 2025 | 32 | 0 |
| 2026 | 21 | 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?
The FDA summary names no predicate by number.
What descends from it? (171)
See all 1713 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?
- Of its descendants, K092521 (Seaspine, Inc., 2010) has gone furthest, with 168 descendants of its own.
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. 2008, 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?
When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-51) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These…
Read the full statement (223 words)
When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-51) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to LS) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period Additionally, Zuma is intended for use with bone graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K082926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082926: Zuma, Model 55-XXXX/56-XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082926
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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