510(k) · Cleared
ClearedNuvasive Coroent Extensure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 12, 2005 as substantially equivalent to K043405 (Nuvasive, Inc., 2005) after a 119-day review. Its family tree reaches back 5 generations to 2001. 263 later devices descend from it.
- Decided
- Dec 12, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010530 (2001). 13 ancestors in all, the oldest K001340 (2000). 263 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- 3 generations backK031914 Spinal Concepts, Inc. Cadence and FortitudeSpinal Concepts, Inc. · 2003
- 2 generations backK033517 Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004 · Recalled
- 1 generation backK043405 Nuvasive Coroent SystemNuvasive, Inc. · 2005 · Recalled
- This deviceK052210 Nuvasive Coroent Extensure SystemNuvasive, Inc. · 2005
- Descendant · cites it directly · 238 of its ownK103666 Lanx LateralLanx, Inc. · 2011
- Descendant · 2 generations on · 147 of its ownK133557 Juliet LL Lateral Lumbar CageSpineart · 2014
- Descendant · 2 generations on · 146 of its ownK141135 Juliet LLSpineart · 2014
- Descendant · 3 generations on · 145 of its ownK161888 JULIET® LL Lateral Lumbar CageSpineart · 2016
- Descendant · 4 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
Showing 5 of 263 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 263 · See all- K103666Lanx LateralLanx, Inc. · 2011 · cites it directly238descendants
- K133557Juliet LL Lateral Lumbar CageSpineart · 2014 · 2 generations on147descendants
- K141135Juliet LLSpineart · 2014 · 2 generations on146descendants
- K161888JULIET® LL Lateral Lumbar CageSpineart · 2016 · 3 generations on145descendants
- K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 4 generations on141descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| −3 | K031914 | Spinal Concepts, Inc. Cadence and Fortitude | Spinal Concepts, Inc. | 2003 | — |
| −2 | K033517 | Spinal Concepts Inc. Cadence and Traxis | Spinal Concepts, Inc. | 2004 | 1 |
| −1 | K043405 | Nuvasive Coroent System | Nuvasive, Inc. | 2005 | 1 |
| 0 (this device) | K052210 | Nuvasive Coroent Extensure System | Nuvasive, Inc. | 2005 | — |
| +1 | K103666 | Lanx Lateral | Lanx, Inc. | 2011 | — |
| +2 | K133557 | Juliet LL Lateral Lumbar Cage | Spineart | 2014 | — |
| +2 | K141135 | Juliet LL | Spineart | 2014 | — |
| +3 | K161888 | JULIET® LL Lateral Lumbar Cage | Spineart | 2016 | — |
| +4 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 0 |
| 2021 | 18 | 0 |
| 2022 | 32 | 0 |
| 2023 | 42 | 0 |
| 2024 | 40 | 0 |
| 2025 | 44 | 0 |
| 2026 | 38 | 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 MQP? 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? (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 |
|---|---|---|---|
| * | K043405 | Nuvasive Coroent System Our reading of the summary gave K043205, FDA’s number for Rusch Easy Tube (Teleflex Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NuVasive CoRoent System”. | 2005 |
What descends from it? (263)
See all 2634 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 4 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K103666 (Lanx, Inc., 2011) has gone furthest, with 238 descendants of its own.
- 3 other devices also cite its predicate K043405.
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.
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?
The NuVasive CoRoent ExtenSure System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052210: Nuvasive Coroent Extensure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052210
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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