510(k) · Cleared
ClearedZUMA
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 Oct 23, 2007 as substantially equivalent to K052170 (Seaspine, Inc., 2005) and 1 other predicate after a 120-day review. Its family tree reaches back 8 generations to 1984. 12 later devices descend from it.
- Decided
- Oct 23, 2007
- Review
- 120 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 30 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK050449 Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005
- 1 generation backK052170 Seaspine VBR SystemSeaspine, Inc. · 2005
- This deviceK071726 ZUMASeaspine, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK124034 Mectalif AnteriorMedacta International · 2013
- Descendant · 2 generations on · 10 of its ownK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- Descendant · 3 generations on · 4 of its ownK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- Descendant · 2 generations on · 2 of its ownK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK232123 MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K124034Mectalif AnteriorMedacta International · 2013 · cites it directly11descendants
- K160605MectaLIF Anterior Stand-AloneMedacta International · 2016 · 2 generations on10descendants
- K170455MectaLIF Anterior Stand AloneMedacta International S.A. · 2017 · 3 generations on4descendants
- K221545MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · 2 generations on2descendants
- K232123MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K050449 | Quantum Vertebral Body Replacement | Quantum Orthopedics, Inc. | 2005 | — |
| −1 | K052170 | Seaspine VBR System | Seaspine, Inc. | 2005 | — |
| 0 (this device) | K071726 | ZUMA | Seaspine, Inc. | 2007 | — |
| +1 | K124034 | Mectalif Anterior | Medacta International | 2013 | — |
| +2 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| +3 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| +2 | K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022 | 6 |
| +3 | K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K052170 | Seaspine VBR SystemSummary page 1…rvertebral Body Fixation Orthosis (MQP, Class 11 -21 CFR 888.3060) Predicate Devices: SeaSpine VBR System (K052 170) Synthes Spine SynFiXTM-LR System (K062083) Device Description: Zuma is a vertebr… | 2005 |
| * | K062083 | Synfix -LRSummary page 1…s 11 -21 CFR 888.3060) Predicate Devices: SeaSpine VBR System (K052 170) Synthes Spine SynFiXTM-LR System (K062083) Device Description: Zuma is a vertebral body replacement device fabricated from PEEK OPTIMA® and titanium. Zumna is de… | 2007 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124034 | Mectalif Anterior | 2013 | 11 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K124034 (Medacta International, 2013) has gone furthest, with 11 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. 2007, 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?
The Zuma 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 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, The Zuma System is intended for use with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071726: ZUMA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071726
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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