Cleared Special

K190696 - Stryker Surgeon iD Mandible Recon Plate

K190696 is an FDA 510(k) clearance for Stryker Surgeon iD Mandible Recon Plate, manufactured by Stryker. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 102-day FDA review.

K190696 · Stryker · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K190696

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
26d faster than avg
Panel avg: 128d · This submission: 102d
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
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K190696.
Depuy Synthes Maxillofacial Portfolio - MR Conditional
K192655 · Synthes USA Products, LLC · Dec 2019
MCI - CMF System
K182758 · Mci Medical Concept Innovation, Inc. · Dec 2019
KLS Martin Individual Patient Solutions
K191028 · KLS-Martin L.P. · Nov 2019
Delphos Implants Rigid Fixation System
K182609 · Delphos Implants - Ind.Com. Importacao E Exportacao DE · Mar 2019
Stryker Facial iD Plating System
K182305 · Stryker · Jan 2019
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
K180204 · Visionare, LLC · Dec 2018
K190696 · Stryker Surgeon iD Mandible Recon Plate
Download PDF FDA Summary Stryker