510(k) · Cleared
ClearedBlackstone Peek Vertebral Body Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 31, 2004 as substantially equivalent to K030744 (Blackstone Medical, Inc., 2003) after a 127-day review. Its family tree reaches back 2 generations to 2001. 1 of the 1,040 devices in its family, counting itself, has a Class I recall. 1,036 later devices descend from it.
- Decided
- Mar 31, 2004
- Review
- 127 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003275 (2001). 3 ancestors in all. 1,036 later devices descend from it, 4 citing it directly. 1 of the 1,040 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 1 generation backK030744 Blackstone Surgical Titanium MeshBlackstone Medical, Inc. · 2003
- This deviceK033702 Blackstone Peek Vertebral Body Replacement SystemBlackstone Medical, Inc. · 2004
- Descendant · cites it directly · 834 of its ownK051246 Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005
- Descendant · cites it directly · 754 of its ownK060350 Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006
- Descendant · 2 generations on · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · cites it directly · 718 of its ownK041939 Blackstone Peek Vertebral Body Replacement System Lordotic Lateral…Blackstone Medical, Inc. · 2004
Showing 5 of 1,036 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 1,036 · See all- K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005 · cites it directly834descendants
- K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006 · cites it directly754descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · 2 generations on753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 3 generations on744descendants
- K041939Blackstone Peek Vertebral Body Replacement System Lordotic Lateral SpacersBlackstone Medical, Inc. · 2004 · cites it directly718descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −1 | K030744 | Blackstone Surgical Titanium Mesh | Blackstone Medical, Inc. | 2003 | — |
| 0 (this device) | K033702 | Blackstone Peek Vertebral Body Replacement System | Blackstone Medical, Inc. | 2004 | — |
| +1 | K051246 | Construx Mini Peek VBR System | Blackstone Medical, Inc. | 2005 | — |
| +1 | K060350 | Construx PL/TL Peek Partial VBR System | Blackstone Medical, Inc. | 2006 | — |
| +2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +1 | K041939 | Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers | Blackstone Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 14 | 0 |
| 2013 | 15 | 0 |
| 2014 | 30 | 0 |
| 2015 | 38 | 0 |
| 2016 | 58 | 0 |
| 2017 | 81 | 0 |
| 2018 | 83 | 0 |
| 2019 | 84 | 0 |
| 2020 | 93 | 0 |
| 2021 | 81 | 1 |
| 2022 | 79 | 0 |
| 2023 | 98 | 0 |
| 2024 | 99 | 0 |
| 2025 | 81 | 0 |
| 2026 | 71 | 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? (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 |
|---|---|---|---|
| * | K030744 | Blackstone Surgical Titanium MeshSummary page 1…ode & Classification: MQP- 888.3060 - Spinal Vertebral Body Replacement Device Substantially Equivalent Devices: Blackstone Surgical Mesh System (K030744) Device Description: Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is comprised of a variety o… | 2003 |
What descends from it? (1,036)
See all 1,0364 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K051246 (Blackstone Medical, Inc., 2005) has gone furthest, with 834 descendants of its own.
- 4 other devices also cite its predicate K030744.
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 Blackstone VBR device is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Blackstone VBR device is also indicated for treating fractures of the thoracic and lumbar spine. The Blackstone VBR device is designed to restore the…
Read the full statement (132 words)
The Blackstone VBR device is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Blackstone VBR device is also indicated for treating fractures of the thoracic and lumbar spine.
The Blackstone VBR device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for prolonged period. Additionally, the VBR device is intended to be used with bone graft. a
The Blackstone VBR device is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used is the Blackstone Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033702 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033702: Blackstone Peek Vertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033702
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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