Cleared Traditional

K132519 - STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT

K132519 is an FDA 510(k) clearance for STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT, manufactured by Stryker. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K132519 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
116d
Days
Class 2
Risk

K132519 is an FDA 510(k) clearance for the STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 116 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. 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker devices

FDA 510(k) Submission Details - K132519

510(k) Number K132519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date December 06, 2013
Days to Decision 116 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 228
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K132519.
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
K133461 · Stryker · Aug 2014
RXG DISTRACTION SYSTEM
K133304 · KLS-Martin L.P. · May 2014
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · Stryker · Jan 2014
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K132600 · Biomet Microfixation · Oct 2013
I-GEN
K131289 · Megagen Implant Co., Ltd. · Sep 2013
SMARTBUILDER SYSTEM (SB1)
K130840 · Osstem Implant Co., Ltd. · Sep 2013