510(k) Report

FDA applicant

Blackstone Medical, Inc.

Springfield, MA45 decisions1997–201011 recalls

FDA records 45 decisions for Blackstone Medical, Inc. (Springfield, MA) from 1997 to 2010: 45 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 138 predicates, 94 of them its own earlier devices. 11 recalls are linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Blackstone Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2008: 92009: 12010: 2
2007high 9 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2013

2009: 22010: 42011: 12013: 2
2007high 4 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Blackstone Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blackstone Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body13decisions
  • KWPAppliance, Fixation, Spinal Interlaminal7decisions
  • MNIOrthosis, Spinal Pedicle Fixation7decisions
  • MQPSpinal Vertebral Body Replacement Device6decisions
  • NKBThoracolumbosacral Pedicle Screw System4decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation3decisions

Also: MAX (2), HRX (1), NQW (1), OVD (1).

Whose devices does it build on?

Its devices cite 138 predicates; 94 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 203 times; 94 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030197Blackstone Posterior Cervical SystemBlackstone Medical, Inc. · 200312cite it
  • K974885Blackstone Medical Inc. Anterior Cervical Plate SystemBlackstone Medical, Inc. · 199810cite it
  • K994217Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 200010cite it
  • K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 20089cite it
  • K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 20029cite it
  • K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 20028cite it

What has FDA decided for it lately?

  • 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
  • K082235Blackstone Pillar XL Peek SpacersBlackstone Medical, Inc. · 2008
  • K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 20081 recall
  • K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc. · 2008

All 45 as Blackstone Medical, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K081684Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product…Nov 26, 2013Class II
  • K080407Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod…Feb 1, 2013Class II
  • K092624Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants…Apr 1, 2011
  • K081684BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self…Oct 22, 2010
  • K081684ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case…Oct 22, 2010
  • K050892Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate…Mar 15, 2010

Other applicant names beginning “Blackstone”

FDA records each applicant name separately; these may or may not be the same firm.

Blackstone & Breglio Industries 1Blackstone 1