Cleared Special

Stryker Surgeon iD Mandible Recon Plate (K190696) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K190696 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
102d
Days
Class 2
Risk

K190696 is an FDA 510(k) clearance for the Stryker Surgeon iD Mandible Recon Plate. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on June 28, 2019 after a review of 102 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K190696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date June 28, 2019
Days to Decision 102 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
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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