Cleared Traditional

K172052 - Arthrex DynaNite Nitinol Staple

K172052 is an FDA 510(k) clearance for Arthrex DynaNite Nitinol Staple, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K172052 · Arthrex, Inc. · Orthopedic device
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Dec 2017
Decision
160d
Days
Class 2
Risk

K172052 is an FDA 510(k) clearance for the Arthrex DynaNite Nitinol Staple. 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 13, 2017 after a review of 160 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 Arthrex, Inc. devices

FDA 510(k) Submission Details - K172052

510(k) Number K172052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2017
Decision Date December 13, 2017
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
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 K172052.
Clench Compression Staple
K173775 · F & A Foundation, LLC D.B.A. Reign Medical · Apr 2018
Orbitum Bone Staple Implant, X and VI
K173693 · Orthovestments, LLC · Feb 2018
ExoToe Staple
K172205 · Exotoe, LLC · Jan 2018
SNIPER STAPLE SYSTEM, NON-STERILE
K172405 · Trilliant Surgical · Dec 2017
Compressyn™ Staple
K171473 · Dallen Medical, Inc. · Nov 2017
JAWS(TM) Nitinol Staple System
K170923 · Paragon 28 · Jul 2017