510(k) · Cleared
ClearedConstrux PL/TL Peek Partial VBR 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 Feb 24, 2006 as substantially equivalent to K051246 (Blackstone Medical, Inc., 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 8 generations to 1984. 1 of the 783 devices in its family, counting itself, has a Class I recall. 754 later devices descend from it.
- Decided
- Feb 24, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 28 ancestors in all. 754 later devices descend from it, 1 citing it directly. 1 of the 783 devices in this family, counting this one, has a Class I recall.
- 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 backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK051246 Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005
- This deviceK060350 Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006
- Descendant · cites it directly · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 3 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 5 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 754 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 754 · See all- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · cites it directly753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 3 generations on696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 5 generations on479descendants
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 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −1 | K051246 | Construx Mini Peek VBR System | Blackstone Medical, Inc. | 2005 | — |
| 0 (this device) | K060350 | Construx PL/TL Peek Partial VBR System | Blackstone Medical, Inc. | 2006 | — |
| +1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +5 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 9 | 0 |
| 2015 | 16 | 0 |
| 2016 | 37 | 0 |
| 2017 | 43 | 0 |
| 2018 | 52 | 0 |
| 2019 | 63 | 0 |
| 2020 | 82 | 0 |
| 2021 | 67 | 1 |
| 2022 | 68 | 0 |
| 2023 | 79 | 0 |
| 2024 | 88 | 0 |
| 2025 | 76 | 0 |
| 2026 | 63 | 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? (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 |
|---|---|---|---|
| * | K051246 | Construx Mini Peek VBR SystemSummary page 1…MQP - 888.3060 -Spinal Intervertebral Body Fixation Orthosis Substantially Equivalent Devices: BlackstoneTM PEEK Mini Vertebral Body Replacement System (K051246) BlackstoneTM PEEK Vertebral Body Replacement System (K033702) Device Description:: Blackstonc Medical, Inc. ConstruxTM PL… | 2005 |
| * | K033702 | Blackstone Peek Vertebral Body Replacement SystemSummary page 1…sis Substantially Equivalent Devices: BlackstoneTM PEEK Mini Vertebral Body Replacement System (K051246) BlackstoneTM PEEK Vertebral Body Replacement System (K033702) Device Description:: Blackstonc Medical, Inc. ConstruxTM PLTL PEEK Partial Vertebral Body Replacement (VBR) System is comprise… | 2004 |
What descends from it? (754)
See all 7541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | 2008 | 753 |
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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K081849 (Blackstone Medical, Inc., 2008) has gone furthest, with 753 descendants of its own.
- 3 other devices also cite its predicate K051246.
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 ConstruxTM PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (T1-5) for partial replacement of 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 Construx TM PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The…
Read the full statement (159 words)
The ConstruxTM PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (T1-5) for partial replacement of 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 Construx TM PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The ConstruxTM PL/TL PEEK Partial VBR 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 of time. The Partial VBR device is intended to be used with bone graft material.
The ConstruxTM PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the ConstruxTM PLITL PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060350: Construx PL/TL Peek Partial 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/K060350
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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