Cleared Traditional

K180544 - DePuy Synthes Static Staples

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

K180544 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K180544

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.

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 197
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