Cleared Traditional

K181781 - DynaClipTM Bone Staple

K181781 is an FDA 510(k) clearance for DynaClipTM Bone Staple, manufactured by MedShape, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K181781 · MedShape, Inc. · Orthopedic device
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Nov 2018
Decision
125d
Days
Class 2
Risk

K181781 is an FDA 510(k) clearance for the DynaClipTM Bone Staple. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by MedShape, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 5, 2018 after a review of 125 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 MedShape, Inc. devices

FDA 510(k) Submission Details - K181781

510(k) Number K181781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2018
Decision Date November 05, 2018
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

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 Peers - JDR Staple, Fixation, Bone

All 197
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K181781.
TriMed Nitinol Staple System
K190166 · TriMed, Inc. · Jul 2019
VERTEX Nitinol Staple System
K182943 · Nvision Biomedical Technologies, LLC · Apr 2019
Geo Staple System
K182212 · Gramercy Extremity Orthopedics, LLC · Jan 2019
DynaBridge
K181815 · Fusion Orthopedics, LLC · Oct 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