Cleared Traditional

K243916 - Primus Spinal Fixation System

K243916 is the FDA 510(k) clearance for Primus Spinal Fixation System by Spinal Elements, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K243916 · Spinal Elements, Inc. · Orthopedic device
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Feb 2025
Decision
63d
Days
Class 2
Risk

K243916 is an FDA 510(k) clearance for the Primus Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 21, 2025 after a review of 63 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 Spinal Elements, Inc. devices

Submission Details

510(k) Number K243916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date February 21, 2025
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K243916.
Eminent Spine 3D Titanium Pedicle Screw System
K241663 · Eminent Spine · Apr 2025
HC Biologics Osteopoint Spinal Fixation System
K250092 · HC Biologics, LLC · Mar 2025
VADER® Pedicle System and VADER®one Pedicle System
K242900 · Icotec AG · Feb 2025
Tiger 2 System
K243908 · Zavation Medical Products, LLC · Feb 2025
TriALTIS™ Spine System
K243249 · Medos International SARL · Jan 2025
EffortMed Spinal Fixation System
K243946 · Effortmed, LLC · Jan 2025