Cleared Traditional

K170773 - Stryker Universal Mesh

K170773 is an FDA 510(k) clearance for Stryker Universal Mesh, manufactured by Stryker. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K170773 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
239d
Days
Class 2
Risk

K170773 is an FDA 510(k) clearance for the Stryker Universal Mesh. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on November 8, 2017 after a review of 239 days - an extended review cycle.

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 - K170773

510(k) Number K170773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2017
Decision Date November 08, 2017
Days to Decision 239 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
112d slower than avg
Panel avg: 127d · This submission: 239d
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 200
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K170773.
OssBuilder System
K172354 · Osstem Implant Co., Ltd. · Mar 2018
KLS Martin L1 MMF System
K173320 · KLS-Martin L.P. · Feb 2018
KLS Martin Individual Patient Solutions
K163579 · KLS-Martin L.P. · 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
MP LeFort I Plates
K171364 · Stryker · Jul 2017