Cleared Special

K171364 - MP LeFort I Plates

K171364 is an FDA 510(k) clearance for MP LeFort I Plates, manufactured by Stryker. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 76-day FDA review.

K171364 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
76d
Days
Class 2
Risk

K171364 is an FDA 510(k) clearance for the MP LeFort I Plates. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on July 24, 2017 after a review of 76 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.

View all Stryker devices

FDA 510(k) Submission Details - K171364

510(k) Number K171364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date July 24, 2017
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 201
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K171364.
Stryker Universal Mesh
K170773 · Stryker · Nov 2017
Stryker Upper-Face AXS screws and Mid-Face AXS screws
K172572 · Stryker · Oct 2017
TruMatch CMF Titanium 3D Printed Implant System
K170272 · Materialise NV · Aug 2017
OPTIMUS CMF SYSTEM
K160363 · Osteonic Co., Ltd. · Oct 2016
Biomet Microfixation OmniMax MMF System
K152326 · Biomet Microfixation · Dec 2015
LeForte System II
K150965 · Jeil Medical Corporation · Sep 2015