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Superion™ 101-9812

by Boston Scientific Neuromodulation

Superion™ 101-9812 is a Class III device made by Boston Scientific Neuromodulation, approved under FDA PMA P140004 on 20 May 2015 and listed in FDA GUDID since 4 Feb 2019 (UDI-DI 00884662000543), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P140004

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884662000543 UDI-DI Date4 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP140004 Date20 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P140004 decided 20 May 2015 Active
  • FDA GUDID UDI-DI 00884662000543 listed 4 Feb 2019 Listed

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2485-2025 FDA Class II initiated 6 Jun 2025

    As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

    • Ongoing Z-1972-2023 FDA Class II initiated 12 May 2023

    Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

    • Ongoing Z-0230-2023 FDA Class II initiated 12 Oct 2022

    Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

Timeline

5 dated events

  1. Approved FDA PMA P140004
  2. Listed FDA GUDID 00884662000543
  3. Recall initiated FDA recalls Z-0230-2023
  4. Recall initiated FDA recalls Z-1972-2023
  5. Recall initiated FDA recalls Z-2485-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Superion™
Generic name
Lumbar decompression interspinous spacer
Model / Ref / Catalog
101-9812
Primary DI / UDI-DI
00884662000543
PMA number
FDA product code
NQO
GMDN term
Lumbar decompression interspinous spacer
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Width — 12 Millimeter

Related devices

Category: Lumbar decompression interspinous spacer

Cleared under the same submission (P140004)

and 2 more cleared under P140004

Similar devices

Other devices filed under FDA product code NQO (Prosthesis, Spinous Process Spacer/Plate).

Other devices from Boston Scientific Neuromodulation

See all devices from Boston Scientific Neuromodulation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)