510(k) · Cleared
ClearedBlackstone Surgical Titanium Mesh
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 Jun 27, 2003 as substantially equivalent to K003275 (Synthes (Usa), 2001) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 2001. 1 of the 1,043 devices in its family, counting itself, has a Class I recall. 1,040 later devices descend from it.
- Decided
- Jun 27, 2003
- Review
- 109 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003275 (2001). 2 ancestors in all. 1,040 later devices descend from it, 5 citing it directly. 1 of the 1,043 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- This deviceK030744 Blackstone Surgical Titanium MeshBlackstone Medical, Inc. · 2003
- Descendant · cites it directly · 1,036 of its ownK033702 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 · 2 generations on · 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
Showing 5 of 1,040 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 1,040 · See all- K033702Blackstone Peek Vertebral Body Replacement SystemBlackstone Medical, Inc. · 2004 · cites it directly1,036descendants
- K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005 · cites it directly834descendants
- K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006 · 2 generations on754descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · 2 generations on753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 3 generations on744descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| 0 (this device) | K030744 | Blackstone Surgical Titanium Mesh | Blackstone Medical, Inc. | 2003 | — |
| +1 | K033702 | Blackstone Peek Vertebral Body Replacement System | Blackstone Medical, Inc. | 2004 | — |
| +1 | K051246 | Construx Mini Peek VBR System | Blackstone Medical, Inc. | 2005 | — |
| +2 | 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 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K030043 | DePuy AcroMed Surgical Titanium Mesh System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 1…alent Devices: DePuy AcroMedTM Surgical Titanium Mesh System (KO03043) Synthes SynMeshTMSpacer System (K003275) Surgical DynamicsTM(SDI) Mesh Cage System (K003709) Device Description: The Blackstone Medical,… | 2001 |
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…(KO03043) Synthes SynMeshTMSpacer System (K003275) Surgical DynamicsTM(SDI) Mesh Cage System (K003709) Device Description: The Blackstone Medical, Inc. Surgical Mesh System is comprised of a hollow cylindrical tube made from co… | 2001 |
What descends from it? (1,040)
See all 1,0405 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?
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 Medical Surgical Mesh System is indicated for use in the thoracolumbar spine (Tl-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 Surgical Mesh is also indicated for treating fractures of the thoracic and lumbar spine. The Surgical Mesh System is designed to restore…
Read the full statement (142 words)
The Blackstone Medical Surgical Mesh System is indicated for use in the thoracolumbar spine (Tl-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 Surgical Mesh is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Mesh 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. It is recommended to pack bone graft material inside the mesh cage prior to implantation.
The Surgical Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Mesh System is the Blackstone Medical Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030744: Blackstone Surgical Titanium Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030744
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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