Superion Indirect Decompression System (IDS)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- SUPERION INTERSPINOUS SPACER FDA PMA
- Generic Name
- Prosthesis, spinous process spacer/plate FDA PMA
Identifiers
- PMA Number
- P140004 FDA PMA
- FDA Product Code
- NQO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Superion Indirect Decompression System (IDS) is an interspinous spacer/plate prosthesis designed to relieve neurogenic intermittent claudication caused by moderate degenerative lumbar spinal stenosis. This device is intended for skeletally mature patients with confirmed radiographic evidence of ligamentum flavum thickening, lateral recess or central canal/foraminal narrowing, and associated nerve root impingement or thecal sac compression.
The Superion ISS is implanted at one or two adjacent lumbar levels (L1–L5) in patients with impaired physical function, as defined by a Zurich Claudication Questionnaire score ≥ 2.0 and the ability to sit for 50 minutes without pain. Supplied sterile and intended for single-use, the device carries FDA PMA approval (P140004) and is classified as a Class III medical device under the NQO product code. Storage and handling must comply with sterile instrument protocols.
Frequently asked questions
What specific lumbar levels can the Superion Indirect Decompression System be implanted at, and how many levels can be treated at once?
The Superion Indirect Decompression System (IDS) is designed for implantation at one or two adjacent lumbar levels, specifically from L1 to L5. It is intended for patients whose symptoms are confined to no more than two levels, ensuring targeted decompression where needed.
How is the Superion ISS packaged and prepared for use, and is it reusable?
The Superion ISS is supplied sterile and is intended for single-use only. This means it must be handled according to sterile instrument protocols to maintain its integrity and prevent contamination before implantation.
What clinical criteria determine if a patient is a suitable candidate for the Superion ISS?
Suitable candidates are skeletally mature patients with neurogenic intermittent claudication caused by moderate degenerative lumbar spinal stenosis, confirmed by radiographic evidence of ligamentum flavum thickening, lateral recess or central canal/foraminal narrowing, and nerve root impingement or thecal sac compression. They must also have impaired physical function (Zurich Claudication Questionnaire score ≥ 2.0), the ability to sit for 50 minutes without pain, and have undergone at least six months of non-operative treatment.
What are the key radiographic and clinical signs that define moderate degenerative lumbar spinal stenosis for this device?
Moderate degenerative lumbar spinal stenosis is defined by a 25% to 50% reduction in the central canal or nerve root canal compared to adjacent levels, confirmed by radiographic studies. Clinically, this includes evidence of thecal sac or cauda equina compression, nerve root impingement, or hypertrophic facets with canal encroachment. Patients must also exhibit moderately impaired physical function (Zurich Claudication Questionnaire score ≥ 2.0) and the ability to sit for 50 minutes without pain.
What storage and handling requirements apply to the Superion ISS to ensure its sterility?
The Superion ISS must be stored and handled in compliance with sterile instrument protocols to preserve its sterility. Since it is intended for single-use, proper packaging and sterile field maintenance are critical to prevent contamination before implantation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P140004 | Class III | Active |
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Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation
Sources (1)
- FDA PMA P140004 24 fields · synced Sep 18, 2026