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ProMIS Extension Rod System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232719

by Premia Spine Ltd

Identifiers

510(k) Number
K232719 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 Extension Rod System is an orthopedic device designed to extend the ProMIS Fixation System to a single adjacent level. It is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws.

The device is supplied as part of a spinal fixation system and is intended for use in orthopedic surgical procedures. It received FDA 510(k) clearance (K232719) on November 21, 2023, and is manufactured by Premia Spine, Ltd. in Ramat Poleg, Netanya, Israel.

Frequently asked questions

What is the ProMIS Extension Rod System used for in spinal surgery?

The ProMIS Extension Rod System is designed to extend the ProMIS Fixation System by one additional adjacent level, allowing surgeons to achieve longer spinal stabilization when needed. It works in conjunction with Premia Spine’s Slender Tulip Polyaxial Pedicle Screws to provide enhanced fixation support during orthopedic spinal procedures.

Is the ProMIS Extension Rod System intended for single-use or can it be reused?

The provided data does not specify reuse instructions, but the device is part of a spinal fixation system typically used in surgical settings where single-use or limited-use protocols are standard for orthopedic implants to ensure patient safety and sterility.

How is the ProMIS Extension Rod System supplied, and what does the package include?

The device is supplied as part of the ProMIS Fixation System, meaning it is intended to be used alongside other components like the Slender Tulip Polyaxial Pedicle Screws. The exact contents of the package are not detailed, but it is likely a sterile, surgical-grade assembly for immediate intraoperative use.

What regulatory pathway did the ProMIS Extension Rod System follow to gain market authorization?

The ProMIS Extension Rod System received FDA 510(k) clearance under the traditional review pathway, classified under product code NKB (Orthopedic Devices for Spinal Fixation). The submission was reviewed by the Orthopedic Devices Panel (OR) and determined to be substantially equivalent to a legally marketed predicate device.

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: PDF Premia Spine Ltd. November 21, 2023 ℅ Janice Hogan Partner Hogan ..., K232719 - ProMIS Extension Rod System - Orthopedic, Premia Spine ProMIS™ - Advanced MIS Lumbar Fusion System, ProMIS Extension Rod System — FDA 510(k) K232719 | MedTracker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Premia Spine Ltd
FDA Applicant
Premia Spine, Ltd.

Sources (1)

  • FDA 510(k) K232719 24 fields · synced Sep 19, 2026