Cleared Traditional

K180544 - DePuy Synthes Static Staples

K180544 is the FDA 510(k) clearance for DePuy Synthes Static Staples by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K180544 · Synthes USA Products, LLC · Orthopedic device
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Jul 2018
Decision
145d
Days
Class 2
Risk

K180544 is an FDA 510(k) clearance for the DePuy Synthes Static Staples. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on July 24, 2018 after a review of 145 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K180544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date July 24, 2018
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 K180544.
DynaClipTM Bone Staple
K181781 · MedShape, Inc. · Nov 2018
DynaBridge
K181815 · Fusion Orthopedics, LLC · Oct 2018
MotoCLIP/HiMAX Step Staple Implant System
K181866 · Crossroads Extremity Systems, LLC · Aug 2018
MotoCLIP/HiMAX Implant System
K181410 · Crossroads Extremity Systems, LLC · Jun 2018
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