Cleared Traditional

K193305 - DynaClip Bone Staple

K193305 is an FDA 510(k) clearance for DynaClip 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 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

FDA 510(k) Submission Details - K193305

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.

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 191
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