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ProMIS™ Fixation System
PREMIA SPINE LTD · Model 87349 · UDI-DI 07290014080997
3
510(k) clearances
24,647
Adverse events (86 deaths)
181
Recalls
409
Facilities
Description
Pre Bent Rod Ø6.0x300mm Hex Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-28 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. |
| 2026-05-22 | Innovasis, Inc | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with unde |
| 2025-09-19 | Orthofix U.S. LLC | Polyaxial screws do not meet performance standards. |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-08-21 | XTANT Medical Holdings, Inc | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and |
| 2024-03-15 | SPINEART SA | Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The |
| 2024-02-28 | SEASPINE ORTHOPEDICS CORPORATION | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.