Cleared Traditional

K203595 - DynaFuse Fixation System

K203595 is the FDA 510(k) clearance for DynaFuse Fixation System by MedShape, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K203595 · MedShape, Inc. · Orthopedic device
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Jan 2022
Decision
391d
Days
Class 2
Risk

K203595 is an FDA 510(k) clearance for the DynaFuse Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by MedShape, Inc. (Atlanta, US). The FDA issued a Cleared decision on January 4, 2022 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 MedShape, Inc. devices

Submission Details

510(k) Number K203595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date January 04, 2022
Days to Decision 391 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
269d slower than avg
Panel avg: 122d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K203595.
JuniOrtho Plating System™
K213572 · Orthofix Srl · Jan 2022
BRM TOOL Screws
K203773 · Brm Extremities Srl · Jan 2022
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
K213199 · Stryker GmbH · Jan 2022
Quick-Start Screws
K212547 · Innovate Orthopaedics Limited · Dec 2021
R3ACT Stabilization System
K211770 · Paragon 28, Inc. · Dec 2021
InCore Subtalar System
K213301 · Nextremity Solutions, Inc. · Dec 2021