Macroporedx Distractor System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K000992 ↗

FDA Product Code

MQN

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Macropore Fx, Ps, Ns, LP

  Class II

  FDA 510(k) K012413 Active Cleared 18 Sep 2001

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  Class II

  FDA 510(k) K031955 Active Cleared 22 Sep 2003

• Macroporens Craniloc

  Class II

  FDA 510(k) K002334 Active Cleared 2 May 2001

• Macropore Hydrosorb Spine System

  Class II

  FDA 510(k) K041105 Active Cleared 28 Jul 2004

• Macropore Os Spinal System

  Class II

  FDA 510(k) K010911 Active Cleared 20 Jul 2001

• Macropore Surgical Barrier Film

  Class II

  FDA 510(k) K023643 Active Cleared 21 Feb 2003

See all devices from Macropore Biosurgery, Inc. →

• What types of clinical settings is the Macroporedx Distractor System intended for use in?

  The Macroporedx Distractor System is designed for use in dental and maxillofacial clinical settings. It is specifically intended for controlled bone distraction and stabilization of the mandible, aiding in the treatment of mandibular defects or deformities through gradual bone lengthening or repositioning.

• Is the Macroporedx Distractor System reusable or intended for single-use?

  The Macroporedx Distractor System is supplied sterile and explicitly intended for single-use only. This ensures patient safety and compliance with regulatory standards for medical devices.

• What regulatory pathway was used for FDA clearance of the Macroporedx Distractor System, and what does this mean for its use?

  The Macroporedx Distractor System received FDA clearance under the Traditional 510(k) pathway (K000992), classified as substantially equivalent to a predicate device. This means it was evaluated for safety and effectiveness against a previously approved device and is regulated under 21 CFR 872.4760, ensuring it meets established standards for External Mandibular Fixators and/or Distractors.

• How many model variants are available for the Macroporedx Distractor System, and how are they identified?

  The Macroporedx Distractor System includes multiple model variants, each identified by unique registration numbers. These include registration numbers such as 1032347, 3000270450, 3015869121, and others listed in the regulatory records. These variants may differ in design or specifications to accommodate various clinical needs.

• What is the shelf-life or storage requirements for the Macroporedx Distractor System?

  The Macroporedx Distractor System is supplied sterile, but specific shelf-life or storage instructions are not detailed in the provided data. Clinicians should follow the manufacturer’s guidelines (Macropore Biosurgery, Inc.) for proper storage to maintain sterility and functionality until use.