Prosthesis, Spinous Process Spacer/Plate
Basic Information
- Device Name
- Prosthesis, Spinous Process Spacer/Plate
- Trade Name
- DIAM Spinal Stabilization System
- PMA Number
- P240043
- Device Class
- FDA Class 3
- Product Code
- NQO
- Generic Name
- Prosthesis, spinous process spacer/plate
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 10, 2025
- Date Received
- December 6, 2024
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQO | Prosthesis, Spinous Process Spacer/Plate | FDA class 3 | Unknown |