Cleared Traditional

K220812 - DynaClip® Bone Staple (FDA 510(k) Clearance)

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

K220812 · MedShape, Inc. · Orthopedic device
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Aug 2022
Decision
151d
Days
Class 2
Risk

K220812 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 August 19, 2022 after a review of 151 days - an extended review cycle.

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 K220812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2022
Decision Date August 19, 2022
Days to Decision 151 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 122d · This submission: 151d
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 230
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K220812.
Linkt Compression Staple System
K250712 · Trax Surgical · May 2025
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
K243888 · Medline Industries, LP · Apr 2025
Arthrex DynaNite Nitinol Staples
K243742 · Arthrex, Inc. · Jan 2025
TMC Compression Implant System
K243658 · Treace Medical Concepts · Dec 2024
TMC Compression Implant System
K242415 · Treace Medical Concepts · Sep 2024
COGNiTiON™ Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024