Cleared Traditional

K180541 - DePuy Synthes 2.0 mm Quick Insertion Sc...

K180541 is the FDA 510(k) clearance for DePuy Synthes 2.0 mm Quick Insertion Sc... by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K180541 · Synthes USA Products, LLC · Orthopedic device
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Nov 2018
Decision
265d
Days
Class 2
Risk

K180541 is an FDA 510(k) clearance for the DePuy Synthes 2.0 mm Quick Insertion Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on November 21, 2018 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K180541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2018
Decision Date November 21, 2018
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 567
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180541.
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