Blackstone Pedicle Screw System

• • Terminated Z-0855-2014 FDA Class II ·initiated 26 Nov 2013 ·on shared 510(k) K081684

  Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.

• • Terminated Z-1674-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010

  There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.

• • Terminated Z-1608-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010

  There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K081684 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Blakstone Laminoplasty Fixation System

  Class II

  FDA 510(k) K043338 Active Cleared 18 Feb 2005

• Blackstone Spinal Fixation System Posterior Hooks

  Class II

  FDA 510(k) K013885 Active Cleared 1 Feb 2002

• Blackstone Peek Vertebral Body Replacement System

  Class II

  FDA 510(k) K033702 Active Cleared 31 Mar 2004

• Modification to Blackstone Modular Pedicle Screw System

  Class II

  FDA 510(k) K042514 Active Cleared 7 Oct 2004

• Blackstone Surgical Titanium Mesh System Angled End Rings

  Class II

  FDA 510(k) K032700 Active Cleared 9 Oct 2003

• Blackstone Ascent Poct System 5.5mm/3.0mm Single Axial Connector

  Class II

  FDA 510(k) K042100 Active Cleared 20 Sep 2004

See all devices from Blackstone Medical, Inc. →

• What is the intended clinical use of the Blackstone Pedicle Screw System?

  This system is designed for posterior, non-cervical pedicle fixation. It is intended to be used in skeletally mature patients to serve as an adjunct to fusion procedures utilizing autograft or allograft.

• What is the regulatory status of this device?

  The Blackstone Pedicle Screw System is authorized under FDA 510(k) clearance K081684, which was granted on September 15, 2008, following a determination of substantial equivalence.

• Who is the manufacturer of this pedicle screw system?

  The Blackstone Pedicle Screw System is manufactured by Blackstone Medical, Inc., located in Wayne, New Jersey.