Cleared Special

K201944 - DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)

K201944 is an FDA 510(k) clearance for DePuy Synthes 2.4mm Ti Self-Tapping Mat..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 59-day FDA review.

K201944 · Synthes USA Products, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
59d
Days
Class 2
Risk

K201944 is an FDA 510(k) clearance for the DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on September 10, 2020 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K201944

510(k) Number K201944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2020
Decision Date September 10, 2020
Days to Decision 59 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 128d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 293
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K201944 · DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
Download PDF FDA Summary Synthes USA Products,…