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INFUSE Bone Graft

by Medtronic Sofamor Danek USA, Inc.

PMA P000054

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

PMA P000054↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP000054 Date30 Apr 2004ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
PMA number
FDA product code
MPW
Device class
Class III
Advisory committee
Orthopedic
FDA decision
APPR Approved

Overview

AI-generated summary, 18 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 recombinant human bone morphogenetic protein (rhBMP-2) delivered via a collagen scaffold, classified as a filler device for osteoinduction. It promotes bone growth and healing by stimulating mesenchymal stem cells to differentiate into bone-forming cells, aiding in the regeneration of bone tissue.

This device is supplied as a sterile, single-use product and is indicated for treating acute, open tibial shaft fractures stabilized with intramedullary (IM) nail fixation, applied within 14 days post-fracture. It is regulated under FDA PMA approval (PMA P000054) and must be used in skeletally mature patients. Storage and handling follow sterile medical device protocols as specified in the accompanying instructions.

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