510(k) Report

510(k) · Cleared

Cleared

Blackstone Surgical Titanium Mesh System Angled End Rings

K032700510(k) SpecialCleared Oct 9, 200337-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Blackstone Medical, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Oct 9, 2003 as substantially equivalent to K030744 (Blackstone Medical, Inc., 2003) after a 37-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.

Decided
Oct 9, 2003
Review
37 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 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2006: 1 descendant clearedK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK030744 · Blackstone Surgical Titanium Mesh · Blackstone Medical, Inc. · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant K030744 · Blackstone Surgical Titanium Mesh · Blackstone Medical, Inc. · 2003K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled0
  1. Root · 2 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 1 generation backK030744 Blackstone Surgical Titanium MeshBlackstone Medical, Inc. · 2003
  3. This deviceK032700 Blackstone Surgical Titanium Mesh System Angled End RingsBlackstone Medical, Inc. · 2003
  4. Descendant · cites it directly · 0 of its ownK061578 SSP Vertebral Body ReplacementSpecialty Spine Products, LLC · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−1K030744Blackstone Surgical Titanium MeshBlackstone Medical, Inc.2003—
0 (this device)K032700Blackstone Surgical Titanium Mesh System Angled End RingsBlackstone Medical, Inc.2003—
+1K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K032700, 2001–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K030744Blackstone Surgical Titanium Mesh
Summary page 1
…assification: MQP- 888.3060 - Spinal Vertebral Body Replacement Device Substantially Equivalent Device: Blackstone Surgical Titanium Mesh System (K030744) Device Description: The Blackstone Medical, Inc. Surgical Titanium Mesh System is comprised of a hollow cylindrical tub…
Blackstone Medical, Inc.2003—

Also cleared against K030744: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC20060

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 2 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, K061578 (Specialty Spine Products, LLC, 2006) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K030744.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Blackstone Medical Surgical Titanium Mesh System is indicated for use in the thoracolumbar 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 Surgical Titanium mesh is also indicated for treating fractures of the thoracic and lumbar spine. The Surgical Titanium Mesh…

Read the full statement (147 words)

The Blackstone Medical Surgical Titanium Mesh System is indicated for use in the thoracolumbar 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 Surgical Titanium mesh is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium 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 Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Titanium Mesh System is the Blackstone Medical Spinal Fixation System.

Indications for use as stated in the FDA summary.

Also cleared against K030744

4 other devices cite the same predicate.

  • K061578SSP Vertebral Body ReplacementSpecialty Spine Products, LLC · 2006
  • K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005
  • K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC · 2005
  • K033702Blackstone Peek Vertebral Body Replacement SystemBlackstone Medical, Inc. · 2004

More from Blackstone Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010
  • K100614Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesBlackstone Medical, Inc. · 2010
  • K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 20091 recall
  • K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
  • K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 20083 recalls

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K032700 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032700: Blackstone Surgical Titanium Mesh System Angled End Rings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032700

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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