Cleared Traditional

DynaBridge (K181815) - FDA 510(k) Clearance

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

K181815 · Fusion Orthopedics, LLC · Orthopedic device
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Oct 2018
Decision
98d
Days
Class 2
Risk

K181815 is an FDA 510(k) clearance for the DynaBridge. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on October 15, 2018 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Fusion Orthopedics, LLC devices

Submission Details

510(k) Number K181815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2018
Decision Date October 15, 2018
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Consultant

The OrthoMedix Group, Inc.
J. D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDR Staple, Fixation, Bone

All 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K181815.
VERTEX Nitinol Staple System
K182943 · Nvision Biomedical Technologies, LLC · Apr 2019
Geo Staple System
K182212 · Gramercy Extremity Orthopedics, LLC · Jan 2019
DynaClipTM Bone Staple
K181781 · MedShape, Inc. · Nov 2018
MotoCLIP/HiMAX Step Staple Implant System
K181866 · Crossroads Extremity Systems, LLC · Aug 2018
DePuy Synthes Static Staples
K180544 · Synthes USA Products, LLC · Jul 2018
MotoCLIP/HiMAX Implant System
K181410 · Crossroads Extremity Systems, LLC · Jun 2018