510(k) · Cleared
ClearedParamount VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Spinal Technologies, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jan 12, 2007 as substantially equivalent to K033517 (Spinal Concepts, Inc., 2004) and 2 other predicates after a 119-day review. Its family tree reaches back 7 generations to 1984. 1 of the 1,428 devices in its family, counting itself, has a Class I recall. 1,406 later devices descend from it.
- Decided
- Jan 12, 2007
- Review
- 119 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 21 ancestors in all. 1,406 later devices descend from it, 1 citing it directly. 1 of the 1,428 devices in this family, counting this one, has a Class I recall.
- 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 backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- This deviceK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · cites it directly · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · 2 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 3 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- Descendant · 3 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
Showing 5 of 1,406 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 1,406 · See all- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · cites it directly1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 2 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 3 generations on1,008descendants
- K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on932descendants
- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 3 generations on907descendants
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 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| 0 (this device) | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +2 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +3 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| +3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 11 | 0 |
| 2009 | 4 | 0 |
| 2010 | 15 | 0 |
| 2011 | 26 | 0 |
| 2012 | 30 | 0 |
| 2013 | 36 | 0 |
| 2014 | 58 | 0 |
| 2015 | 67 | 0 |
| 2016 | 87 | 0 |
| 2017 | 105 | 0 |
| 2018 | 105 | 0 |
| 2019 | 107 | 0 |
| 2020 | 104 | 0 |
| 2021 | 103 | 1 |
| 2022 | 100 | 0 |
| 2023 | 134 | 0 |
| 2024 | 124 | 0 |
| 2025 | 101 | 0 |
| 2026 | 88 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K033517 | Spinal Concepts Inc. Cadence and TraxisSummary page 1…olumbar spine (T1 to L5) with or without supplemental fixation, such as the ParamountTM Pedicle Screw System. PREDICATE DEVICES: Spinal Concepts Inc. TRAXIS TM (K033517), Pioneer® Vertebral Spacer (K043206), and SpineVision Spacevision T M Cage (K042930). PERFORMANCE DATA: The mechanical test re… | 2004 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 1…out supplemental fixation, such as the ParamountTM Pedicle Screw System. PREDICATE DEVICES: Spinal Concepts Inc. TRAXIS TM (K033517), Pioneer® Vertebral Spacer (K043206), and SpineVision Spacevision T M Cage (K042930). PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267… | 2005 |
| * | K042930 | Spacevision Cage SystemSummary page 1…TM Pedicle Screw System. PREDICATE DEVICES: Spinal Concepts Inc. TRAXIS TM (K033517), Pioneer® Vertebral Spacer (K043206), and SpineVision Spacevision T M Cage (K042930). PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Pa… | 2004 |
What descends from it? (1,406)
See all 1,4061 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072120 | Paramount Intervertebral Body Fusion Device | 2007 | 1,405 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 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.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K072120 (Innovative Spinal Technologies, Inc., 2007) has gone furthest, with 1,405 descendants of its own.
- 5 other devices also cite its predicate K033517.
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 ParamountTM VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ParamountTM VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the ParamountTM Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062759 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062759: Paramount VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062759
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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