Prosthesis, Spinous Process Spacer/Plate
Basic Information
- Device Name
- Prosthesis, Spinous Process Spacer/Plate
- Trade Name
- X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
- PMA Number
- P040001
- Supplement Number
- S002
- 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
- August 8, 2006
- Date Received
- March 1, 2006
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE X STOPPK, A MODIFIED VERSION OF THE X STOP THAT INCLUDES A PEEK SPACER AND ADDITIONAL 16 MM SPACER SIZE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X STOPPK AND IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND/OR CT EVIDENCE OF THICKENING LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CONAL NARROWING). THE X STOPPK IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT. THE X STOPPK MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
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 |