Cleared Traditional

ProMIS Extension Rod System (K232719) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232719 · Premia Spine, Ltd. · Orthopedic device
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Nov 2023
Decision
77d
Days
Class 2
Risk

K232719 is an FDA 510(k) clearance for the ProMIS Extension Rod System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Premia Spine, Ltd. (Ramat Poleg, Netanya, IL). The FDA issued a Cleared decision on November 21, 2023 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Premia Spine, Ltd. devices

Submission Details

510(k) Number K232719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2023
Decision Date November 21, 2023
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K232719.
ARx MIS Spinal Screw System
K233455 · Life Spine, Inc. · Dec 2023
TriALTIS™ Spine System
K233684 · Medos International SARL · Dec 2023
Mini-OSTEO Pedicle Fixation System
K231443 · Osteomed Ind?stria E Com?rcio DE Implantes Ltda · Nov 2023
MASADA Modular Spinal Fixation System
K231694 · Astura Medical · Nov 2023
ANAX™ 5.5 Spinal System
K231737 · Innosys Co., Ltd. · Oct 2023
PressON Spinal Fixation System
K233234 · Nexus Spine, LLC · Oct 2023