510(k) · Cleared
ClearedSeaspine VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 21, 2005 as substantially equivalent to K050553 (Alphatec/Nexmed, 2005) and 6 other predicates after a 134-day review. Its family tree reaches back 7 generations to 1984. 13 later devices descend from it.
- Decided
- Dec 21, 2005
- Review
- 134 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K841189 (1984). 27 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 1 generation backK050449 Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005
- This deviceK052170 Seaspine VBR SystemSeaspine, Inc. · 2005
- Descendant · cites it directly · 12 of its ownK071726 ZUMASeaspine, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK124034 Mectalif AnteriorMedacta International · 2013
- Descendant · 3 generations on · 10 of its ownK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- Descendant · 4 generations on · 4 of its ownK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- Descendant · 3 generations on · 2 of its ownK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K071726ZUMASeaspine, Inc. · 2007 · cites it directly12descendants
- K124034Mectalif AnteriorMedacta International · 2013 · 2 generations on11descendants
- K160605MectaLIF Anterior Stand-AloneMedacta International · 2016 · 3 generations on10descendants
- K170455MectaLIF Anterior Stand AloneMedacta International S.A. · 2017 · 4 generations on4descendants
- K221545MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −1 | K050449 | Quantum Vertebral Body Replacement | Quantum Orthopedics, Inc. | 2005 | — |
| 0 (this device) | K052170 | Seaspine VBR System | Seaspine, Inc. | 2005 | — |
| +1 | K071726 | ZUMA | Seaspine, Inc. | 2007 | — |
| +2 | K124034 | Mectalif Anterior | Medacta International | 2013 | — |
| +3 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| +4 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| +3 | K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K050553 | Novel VBR Spinal SystemSummary page 1…vice Trade Name: SeaSpine VBR System The devices used for comparison in this summary are the Aiphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replace… | 2005 |
| * | K042201 | Novel VBR Spinal SystemSummary page 1…ame: SeaSpine VBR System The devices used for comparison in this summary are the Aiphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K05044… | 2004 |
| * | K010530 | Geo StructureSummary page 1…evices used for comparison in this summary are the Aiphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K03351 7).… | 2001 |
| * | K020048 | Modification to Geo StructureSummary page 1…ed for comparison in this summary are the Aiphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K03351 7). 1. Int… | 2002 |
| * | K040168 | Modification to Geo StructureSummary page 1…ison in this summary are the Aiphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K03351 7). 1. Intended Use: (T… | 2004 |
| * | K050449 | Quantum Vertebral Body ReplacementSummary page 1…NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K03351 7). 1. Intended Use: (The statements of intended use are identical.) The… | 2005 |
| * | K033517 | Spinal Concepts Inc. Cadence and TraxisSummary page 1…he Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K03351 7). 1. Intended Use: (The statements of intended use are identical.) The intended use of the SeaSpine VBR System straight,… | 2004 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071726 | ZUMA | 2007 | 12 |
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 21 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K071726 (Seaspine, Inc., 2007) has gone furthest, with 12 descendants of its own.
- 7 other devices also cite its predicate K050553.
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 SeaSpine VBR System is intended for use in the thoracolumbar spine (TI to L5) 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 SeaSpine VBR 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, the SeaSpine VBR System is intended for use with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052170: Seaspine VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052170
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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