Cleared Traditional

K243565 - DYNAMIS SI Screw System

K243565 is an FDA 510(k) clearance for DYNAMIS SI Screw System, manufactured by Promethean Restorative, LLC. The device is a Class 2 Orthopedic device with product code OUR cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K243565 · Promethean Restorative, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
102d
Days
Class 2
Risk

K243565 is an FDA 510(k) clearance for the DYNAMIS™ SI Screw System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Promethean Restorative, LLC (Castle Rock, US). The FDA issued a Cleared decision on February 28, 2025 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Promethean Restorative, LLC devices

FDA 510(k) Submission Details - K243565

510(k) Number K243565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2024
Decision Date February 28, 2025
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OUR Device Classification - Class 2, Special Controls

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint 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 - OUR Sacroiliac Joint Fixation

All 119
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K243565.
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TiLink-P Joint Fusion System
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K242141 · SurGenTec, LLC · Aug 2024