Identifiers
- 510(k) Number
- K150380 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ProMIS Fixation System is a spinal fixation device classified under orthopedic implants, designed for lumbar spine stabilization. It consists of components such as pre-bent rods and fixation hardware intended to provide structural support during spinal fusion procedures. This system is engineered to facilitate minimally invasive surgical techniques, reducing tissue disruption compared to traditional open surgery approaches. Its design aims to enhance postoperative recovery and long-term spinal stability in patients requiring lumbar stabilization.
The ProMIS Fixation System is supplied as a sterile, single-use device intended for surgical implantation by qualified orthopedic surgeons. It includes components like pre-bent rods (e.g., Ø6.0×160mm blunt edge) and is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to predicate devices. The system is intended for use in MRI-unsafe environments due to metallic components and must be stored in accordance with manufacturer guidelines to maintain sterility. Authorized by Premia Spine Ltd., it adheres to ISO 13485 quality management standards for medical devices.
Frequently asked questions
What is the ProMIS Fixation System used for?
The ProMIS Fixation System is designed for lumbar spine stabilization during spinal fusion surgeries. It provides structural support to the spine, helping to maintain alignment and stability post-surgery. Its pre-bent rods and fixation hardware are engineered to reduce tissue disruption, enabling minimally invasive techniques that can shorten recovery times and improve patient outcomes.
Is the ProMIS Fixation System single-use or reusable?
The ProMIS Fixation System is intended for single-use only. It is supplied sterile to ensure patient safety and compliance with medical device standards, preventing cross-contamination and maintaining efficacy for one surgical procedure.
What are the key components of the ProMIS Fixation System?
The system includes pre-bent rods, such as the Ø6.0×160mm blunt-edge rod, along with fixation hardware tailored for lumbar spine stabilization. These components are designed to work together to provide secure and stable fixation during spinal fusion surgeries.
Can the ProMIS Fixation System be used in MRI environments?
No, the ProMIS Fixation System is not MRI-safe due to its metallic components. It should only be used in non-MRI environments to avoid interference with imaging and potential safety risks for patients.
How should the ProMIS Fixation System be stored to maintain sterility?
The system must be stored according to the manufacturer’s guidelines to preserve sterility. This typically involves keeping it in its original packaging, in a clean and dry environment, protected from contamination, moisture, and physical damage until ready for surgical use.
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. Sources consulted: Premia Spine ProMIS™ - Advanced MIS Lumbar Fusion System, Spine Surgery Implants to Cure Spinal Conditions | Premia Spine, ProMIS™ Fixation System - SPINEMarketGroup, PREMIA SPINE LTD 87503 ProMIS™ Fixation System - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150380 | Class II | Active |
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Manufacturer
- Manufacturer
- Premia Spine Ltd
- FDA Applicant
- Premia Spine, Ltd.
Sources (1)
- FDA 510(k) K150380 24 fields · synced Oct 1, 2026