Cleared Traditional

K193305 - DynaClip Bone Staple

K193305 is the FDA 510(k) clearance for DynaClip Bone Staple by MedShape, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K193305 · MedShape, Inc. · Orthopedic device
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Apr 2020
Decision
146d
Days
Class 2
Risk

K193305 is an FDA 510(k) clearance for the DynaClip 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 April 23, 2020 after a review of 146 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

Submission Details

510(k) Number K193305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2019
Decision Date April 23, 2020
Days to Decision 146 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 slower than avg
Panel avg: 122d · This submission: 146d
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 Peers - JDR Staple, Fixation, Bone

All 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K193305.
Medline UNITE REFLEX Nitinol Staple System
K210482 · Medline Industries, Inc. · Apr 2021
Ligament Staple
K210456 · Medacta International S.A. · Apr 2021
Arthrex DynaNite Nitinol Staples
K203180 · Arthrex, Inc. · Dec 2020
Superelastic Staple
K192447 · Neosteo · Feb 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · Synthes USA Products, LLC · Feb 2020
TriMAX Implant System
K190722 · Crossroads Extemity Systems, LLC · Aug 2019