510(k) · Cleared
ClearedBlackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers
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 Aug 17, 2004 as substantially equivalent to K033702 (Blackstone Medical, Inc., 2004) after a 29-day review. Its family tree reaches back 3 generations to 2001. 718 later devices descend from it.
- Decided
- Aug 17, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003275 (2001). 4 ancestors in all. 718 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 2 generations backK030744 Blackstone Surgical Titanium MeshBlackstone Medical, Inc. · 2003
- 1 generation backK033702 Blackstone Peek Vertebral Body Replacement SystemBlackstone Medical, Inc. · 2004
- This deviceK041939 Blackstone Peek Vertebral Body Replacement System Lordotic Lateral…Blackstone Medical, Inc. · 2004
- Descendant · cites it directly · 712 of its ownK043405 Nuvasive Coroent SystemNuvasive, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 666 of its ownK051454 Aleutian Spacer SystemK2m, LLC · 2005
- Descendant · 3 generations on · 663 of its ownK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- Descendant · 3 generations on · 662 of its ownK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- Descendant · 4 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
Showing 5 of 718 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 718 · See all- K043405Nuvasive Coroent SystemNuvasive, Inc. · 2005 · cites it directly712descendants
- K051454Aleutian Spacer SystemK2m, LLC · 2005 · 2 generations on666descendants
- K063399Aleutian Spacer SystemK2m, Inc. · 2007 · 3 generations on663descendants
- K082698Aleutian Ibf SystemK2m, Inc. · 2009 · 3 generations on662descendants
- K101302Aleutian Ibf SystemK2m, Inc. · 2010 · 4 generations on595descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −2 | K030744 | Blackstone Surgical Titanium Mesh | Blackstone Medical, Inc. | 2003 | — |
| −1 | K033702 | Blackstone Peek Vertebral Body Replacement System | Blackstone Medical, Inc. | 2004 | — |
| 0 (this device) | K041939 | Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers | Blackstone Medical, Inc. | 2004 | — |
| +1 | K043405 | Nuvasive Coroent System | Nuvasive, Inc. | 2005 | 1 |
| +2 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| +3 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| +3 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| +4 | K101302 | Aleutian Ibf System | K2m, 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 |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 15 | 0 |
| 2015 | 18 | 0 |
| 2016 | 18 | 0 |
| 2017 | 40 | 0 |
| 2018 | 52 | 0 |
| 2019 | 47 | 0 |
| 2020 | 63 | 0 |
| 2021 | 62 | 0 |
| 2022 | 70 | 0 |
| 2023 | 86 | 0 |
| 2024 | 84 | 0 |
| 2025 | 66 | 0 |
| 2026 | 56 | 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? (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 |
|---|---|---|---|
| * | K033702 | Blackstone Peek Vertebral Body Replacement SystemSummary page 1…al Body Replacement Device Substantially Equivalent Devices: Blackstone PEEK Vertebral Body Replacement System (K033702) Device Description: Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is comprised of a variety o… | 2004 |
What descends from it? (718)
See all 7182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K043405 (Nuvasive, Inc., 2005) has gone furthest, with 712 descendants of its own.
- 3 other devices also cite its predicate K033702.
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 a prolonged period. Additionally, the VBR device is intended to be used with bone graft.
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/K041939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041939: Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041939
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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