Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Orthopedic · 21 CFR 890.5870
A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.
Recent MDR events
29 adverse event reports on file
- SONICATOR 740XJun 5, 2015MalfunctionMettler Electronics Corp.4837611
- EXOGEN 4000 SYSTEMMay 28, 2014InjuryBioventusMW5036389
- BIOVENTUS EXOGEN 4000+ SYSTEMAug 29, 2013InjuryBioventus,llc3010203571-2013-00003
- SAFHS 2000 MOU ASSEMBLYJul 25, 2013OtherBioventus Llc3010203571-2013-00002
- EXOGEN 4000+ SYSTEM EXPORTMay 28, 2013InjuryBioventus Llc3010203571-2013-00001
- EXOGENMay 8, 2012InjurySmith & Nephew, Inc.1020279-2012-00263
- EXOGENApr 3, 2012InjurySmith & Nephew Orthopaedics, Inc.1020279-2012-00210
- EXOGEN 4000Mar 21, 2012InjurySmith & Nephew Orthopaedics, Inc.1020279-2012-00178
- EXOGEN 4000Feb 24, 2012InjurySmith & Nephew Orthopaedics1020279-2012-00107
- SAFHS 2000 MOU ASSEMBLYDec 13, 2011InjurySmith & Nephew Orthopaedics1020279-2011-00524
Event type breakdown
Recalls
2 recall events for this product code
- Smith & Nephew IncTerminatedAug 4, 2009
Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116.
Problems with transducer may result in a reduced ultrasound output.
Z-1695-2009 · View FDA record ↗ - Smith & Nephew IncTerminatedAug 4, 2009
Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distribu
Problems with transducer may result in a reduced ultrasound output.
Z-1696-2009 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.