LOF · Stimulator, Bone Growth, Non-Invasive
Orthopedic · 21 CFR 890.5870 · Class 2
Overview
| Product Code | LOF |
|---|---|
| Device Name | Stimulator, Bone Growth, Non-Invasive |
| Regulation | 21 CFR 890.5870 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Identification
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 Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P210016 | ManaFuse | Enovis | Jan 17, 2025 | APRL |
| P230025 | Xstim Spine Fusion Stimulator | Xstim, Inc. | Feb 9, 2024 | APPR |
| P210035 | AccelStimTM Bone Growth Stimulator | Orthofix US, LLC | May 3, 2022 | APRL |
| P190030 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | Dec 9, 2020 | APRL |
| P030034 | CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM | Orthofix, Inc. | Dec 23, 2004 | APRL |
| P900009 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | Bioventus, LLC | Oct 5, 1994 | APRL |
| P910066 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | Djo, LLC | Mar 4, 1994 | APRL |
| P850007 | PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 | Orthofix, Inc. | Feb 21, 1986 | APRL |
| P850022 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy | Ahp Eos Buyer, Inc. | Feb 18, 1986 | APRL |
| P790002 | Biomet(R) EBI BONE Healing System | Ahp Eos Buyer, Inc. | Nov 6, 1979 | APRL |
Top Applicants
- Ahp Eos Buyer, Inc. — 2 clearances
- Orthofix, Inc. — 2 clearances
- Bioventus, LLC — 1 clearance
- Djo, LLC — 1 clearance
- Enovis — 1 clearance
