Cleared Traditional

K203180 - Arthrex DynaNite Nitinol Staples

K203180 is the FDA 510(k) clearance for Arthrex DynaNite Nitinol Staples by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K203180 · Arthrex, Inc. · Orthopedic device
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Dec 2020
Decision
51d
Days
Class 2
Risk

K203180 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 December 16, 2020 after a review of 51 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 K203180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2020
Decision Date December 16, 2020
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 K203180.
FuseForce™ Flex Dynamic Compression System
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Medline UNITE REFLEX Nitinol Staple System
K210482 · Medline Industries, Inc. · Apr 2021
Ligament Staple
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DynaClip Bone Staple
K193305 · MedShape, Inc. · Apr 2020
Superelastic Staple
K192447 · Neosteo · Feb 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · Synthes USA Products, LLC · Feb 2020