Stimulator, Bone Growth, Non-invasive
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
1,433 adverse event reports on file
- BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEMJul 22, 2026InjuryEbi, Llc.0002242816-2026-00092
- BIOMET SPINALPAK / ORTHOPAKJul 21, 2026InjuryEbi, Llc.0002242816-2026-00089
- BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEMJul 21, 2026InjuryEbi, Llc.0002242816-2026-00091
- BIOMET EBI BONE HEALING SYSTEMJul 20, 2026InjuryEbi, Llc.0002242816-2026-00087
- BIOMET EBI BONE HEALING SYSTEMJul 20, 2026InjuryEbi, Llc.0002242816-2026-00088
- BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEMJul 13, 2026InjuryEbi, Llc.0002242816-2026-00084
- BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEMJul 13, 2026InjuryEbi, Llc.0002242816-2026-00085
- BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEMJul 13, 2026InjuryEbi, Llc.0002242816-2026-00086
- BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEMJun 30, 2026InjuryEbi, Llc.0002242816-2026-00080
- OSTEOGENESIS STIMULATOR, CERVICAL-STIMJun 26, 2026InjuryOrthofix, Llc2183449-2026-00026
Event type breakdown
Recalls
5 recall events for this product code
- EBI, LLCOpen, ClassifiedApr 23, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Z-1616-2024 · View FDA record ↗ - EBI, LLCOpen, ClassifiedApr 23, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Z-1617-2024 · View FDA record ↗ - EBI, LLCOpen, ClassifiedApr 23, 2024
20" Lead Wires, Replacement
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Z-1618-2024 · View FDA record ↗ - EBI, LLCOpen, ClassifiedApr 23, 2024
48" Lead Wires, Replacement
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Z-1619-2024 · View FDA record ↗ - Bioventus, LLCTerminatedUnknown
EXOGEN Ultrasound Coupling Gel
Product may contain white particulates that are microbial in nature.
Z-0810-2021 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Djo, Llc
Carlsbad, CA, US
Orthofix Us Llc
Lewisville, TX, US
Xstim Inc.
Irving, TX, US
Highridge Medical, Llc
Westminster, CO, US
Theragen, Inc.
Jacksonville, FL, US
Bioventus Llc
Durham, NC, US
Igea Spa
Carpi (MO) Modena, IT
Bioventus Llc
Cordova, TN, US
Ebi Patient Care, Inc.
GUAYNABO, PR, US
Jkh Health Co., Ltd.
Dongguan Guangdong, CN
Seko Medtec Solutions
Oakdale, PA, US
Just Keep Healthy Co., Ltd.
Samkkei Munichay District Kampong Speu, KH
Ebi, Llc
PARSIPPANY, NJ, US
Olive Branch Distribution Center
Olive Branch, MS, US
Creation Technologies Ltd
Mississauga Ontario, CA
Djo, Llc
Vista, CA, US
Clearlake-tech Inc
Clear Lake, SD, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.