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Infuse Bone Graft

by Medtronic, Inc.

PMA P050053

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P050053↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP050053 Date9 Mar 2007ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0440-2019 FDA Class II initiated 27 Sep 2018 on shared PMA P050053

    The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Bone grafting material, dental, with biologic component
PMA number
FDA product code
NPZ
Device class
Class III
Regulation
21 CFR Part 872.3930
Advisory committee
Dental
FDA decision
APPR Approved

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Infuse Bone Graft is a bone grafting material, dental, with biologic component, classified under FDA’s Class III regulatory pathway. It is designed as an alternative to autogenous bone graft for sinus augmentations and localized alveolar ridge augmentations in extraction socket defects. The device leverages recombinant human bone morphogenetic protein-2 (rhBMP-2) to stimulate bone regeneration.

Infuse Bone Graft is supplied as a sterile, single-use product and is approved under FDA PMA (P050053) for dental applications. It is intended for use in controlled surgical settings, where precise placement is required. The device is regulated under 21 CFR 872.3930 and is distributed in multiple registration numbers (e.g., 3007884119, 3008816891). Storage and handling must comply with manufacturer guidelines to maintain sterility.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What specific dental procedures is the Infuse Bone Graft approved for, and why is it considered an alternative to autogenous bone graft?

    The Infuse Bone Graft is FDA-approved for sinus augmentations and localized alveolar ridge augmentations in extraction socket defects, serving as an alternative to autogenous bone graft. It uses recombinant human bone morphogenetic protein-2 (rhBMP-2) to stimulate bone regeneration, eliminating the need for harvesting bone from the patient’s own body while still promoting natural healing and bone growth in these targeted areas.

  • Is the Infuse Bone Graft reusable, and if not, how should it be handled to maintain sterility?

    No, the Infuse Bone Graft is designed as a sterile, single-use product. To preserve sterility, it must be stored and handled according to Medtronic’s guidelines—typically in a sealed, unopened package until immediately before use, and only opened in a controlled surgical setting where contamination risks are minimized.

  • What regulatory pathway does the Infuse Bone Graft follow, and how does that affect its use in clinical settings?

    The Infuse Bone Graft is classified under FDA’s Class III regulatory pathway and approved via a Premarket Approval (PMA) under PMA number P050053. This means it is strictly regulated for safety and efficacy, requiring use only in controlled surgical environments where precise placement—such as sinus lifts or extraction socket defects—is critical. Clinicians must adhere to FDA’s approved indications and Medtronic’s instructions to ensure proper application.

  • Are there different sizes or models of the Infuse Bone Graft, and if so, how might a clinician determine the appropriate one for a patient?

    While the provided data does not specify exact sizes or models, the Infuse Bone Graft is tailored for sinus augmentations and localized alveolar ridge augmentations, implying variability in delivery systems (e.g., collagen sponge carriers) to accommodate different defect sizes. Clinicians should refer to Medtronic’s surgical technique guides or consult with their account representative to select the appropriate formulation or carrier based on the patient’s anatomical requirements and defect dimensions.