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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceDIAM­™ Spinal Stabilization System
Generic NameProsthesis, spinous process spacer/plate
ApplicantCompanion Spine France Sas
Immeuble Le Bridge 5
5 Allee Des Acacias
Merignac 33 70
PMA NumberP240043
Date Received12/06/2024
Decision Date12/10/2025
Product Code NQO 
Advisory Committee Orthopedic
Clinical TrialsNCT00456378
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The DIAM™ Spinal Stabilization System is indicated for skeletally mature patients that have moderate to severe primary low back pain (greater than leg pain) secondary to lumbar degenerative disc disease (DDD), at a single level from L2-L5 with current episode refractory to at least 6 months of non-operative care.Symptomatic disc disease is confirmed by patient history, physical examination, and radiographic evaluation with one or more of the following factors:• Greater than 2mm of decreased disc height (average disc height) compared to the adjacent level• Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule • Non-extruded herniated nucleus pulposusThe DIAM™ device is implanted via a minimally invasive posterior approach.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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