510(k) · Cleared
ClearedZUMA-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Apr 13, 2010 as substantially equivalent to K082309 (Seaspine, Inc., 2009) and 2 other predicates after a 238-day review. Its family tree reaches back 4 generations to 2001. 168 later devices descend from it.
- Decided
- Apr 13, 2010
- Review
- 238 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010530 (2001). 10 ancestors in all, the oldest P950002 (1996). 168 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 3 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 2 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 1 generation backK072981 Synthes Zero-PSynthes Spine Co.Lp · 2008 · Recalled
- This deviceK092521 ZUMA-CSeaspine, Inc. · 2010
- Descendant · cites it directly · 131 of its ownK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- Descendant · 2 generations on · 99 of its ownK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 61 of its ownK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
Showing 5 of 168 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 168 · See all- K102547Coroent Interlock SystemNuvasive, Inc. · 2011 · cites it directly131descendants
- K142299CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014 · 2 generations on99descendants
- K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · 2 generations on94descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 3 generations on83descendants
- K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017 · cites it directly61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −3 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −2 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −1 | K072981 | Synthes Zero-P | Synthes Spine Co.Lp | 2008 | 2 |
| 0 (this device) | K092521 | ZUMA-C | Seaspine, Inc. | 2010 | — |
| +1 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| +2 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +3 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +1 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 17 | 0 |
| 2023 | 25 | 0 |
| 2024 | 27 | 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 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? (3)
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 |
|---|---|---|---|
| * | K082309 | CambriaSummary page 1…nous bone graft and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation. - K082309 Cambria™ (SeaSpine, Inc.) K082926 Zuma™ (SeaSpine, Inc.) K072981 Zero-P™ (Synthes Spine) Zuma-C was shown to be substanfiallv e… | 2009 |
| * | K082926 | Zuma, Model 55-XXXX/56-XXXXSummary page 1…n open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation. - K082309 Cambria™ (SeaSpine, Inc.) K082926 Zuma™ (SeaSpine, Inc.) K072981 Zero-P™ (Synthes Spine) Zuma-C was shown to be substanfiallv equivalent to predicate devices thro… | 2008 |
| * | K072981 | Synthes Zero-PSummary page 1…-C is intended to be used with the bone screw fixation provided and requires no additional fixation. - K082309 Cambria™ (SeaSpine, Inc.) K082926 Zuma™ (SeaSpine, Inc.) K072981 Zero-P™ (Synthes Spine) Zuma-C was shown to be substanfiallv equivalent to predicate devices through comparison in areas includi… | 2008 |
What descends from it? (168)
See all 1683 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 9 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K102547 (Nuvasive, Inc., 2011) has gone furthest, with 131 descendants of its own.
- 2 other devices also cite its predicate K082309.
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. 2010, 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?
Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.
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/K092521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092521: ZUMA-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092521
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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