3Spine announced completion of the 50th MOTUS lumbar total joint replacement in the U.S. under FDA Investigational Device Exemption (IDE) and the 150th Real-World Evidence (RWE) lumbar fusion control case. This second milestone marks full enrollment of the RWE fusion study, allowing all eligible sites to recruit MOTUS patients upon conversion.
3Spine’s lumbar total joint replacement procedure and MOTUS device is a first-of-kind technology that replaces the function of the disc and facet joints through a posterior approach. Much like a hip or knee total joint replacement, the technique reconstructs the functional spinal unit. The procedure is intended to broadly address leg pain, back pain and spinal instability, while correcting posture and preserving freedom of movement in patients suffering from spinal stenosis, facet arthritis and other degenerative changes. Lumbar total joint replacement received FDA Breakthrough Device Designation in 2020 and is currently tracked under CPT code 0719T.
The 150-patient RWE cohort will be propensity score matched to a 150-patient IDE cohort at two years. U.S. regulatory clearance is expected in 2025. 3Spine is seeking single-level indications from L1-S1 in patients suffering from lumbar degeneration with or without foraminal or recess spinal stenosis with no more than a grade 1 spondylolisthesis at the involved level.
3Spine announced completion of the 50th MOTUS lumbar total joint replacement in the U.S. under FDA Investigational Device Exemption (IDE) and the 150th Real-World Evidence (RWE) lumbar fusion control case. This second milestone marks full enrollment of the RWE fusion study, allowing all eligible sites to recruit MOTUS patients upon conversion. ...
3Spine announced completion of the 50th MOTUS lumbar total joint replacement in the U.S. under FDA Investigational Device Exemption (IDE) and the 150th Real-World Evidence (RWE) lumbar fusion control case. This second milestone marks full enrollment of the RWE fusion study, allowing all eligible sites to recruit MOTUS patients upon conversion.
3Spine’s lumbar total joint replacement procedure and MOTUS device is a first-of-kind technology that replaces the function of the disc and facet joints through a posterior approach. Much like a hip or knee total joint replacement, the technique reconstructs the functional spinal unit. The procedure is intended to broadly address leg pain, back pain and spinal instability, while correcting posture and preserving freedom of movement in patients suffering from spinal stenosis, facet arthritis and other degenerative changes. Lumbar total joint replacement received FDA Breakthrough Device Designation in 2020 and is currently tracked under CPT code 0719T.
The 150-patient RWE cohort will be propensity score matched to a 150-patient IDE cohort at two years. U.S. regulatory clearance is expected in 2025. 3Spine is seeking single-level indications from L1-S1 in patients suffering from lumbar degeneration with or without foraminal or recess spinal stenosis with no more than a grade 1 spondylolisthesis at the involved level.
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