Cleared Traditional

K243742 - Arthrex DynaNite Nitinol Staples (FDA 510(k) Clearance)

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

K243742 · Arthrex, Inc. · Orthopedic device
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Jan 2025
Decision
58d
Days
Class 2
Risk

K243742 is an FDA 510(k) clearance for the Arthrex DynaNite Nitinol Staples. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on January 31, 2025 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K243742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2024
Decision Date January 31, 2025
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K243742.
Linkt Compression Staple System
K250712 · Trax Surgical · May 2025
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
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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
A’TOMIC™ Nitinol Fixation System
K232990 · Rmr Ortho, LLC · Jan 2024