Cleared Traditional

K022185 - UNIVERSAL CMF SYSTEM

K022185 is the FDA 510(k) clearance for UNIVERSAL CMF SYSTEM by Stryker Instruments. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K022185 · Stryker Instruments · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
167d
Days
Class 2
Risk

K022185 is an FDA 510(k) clearance for the UNIVERSAL CMF SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on December 17, 2002 after a review of 167 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.

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Submission Details

510(k) Number K022185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date December 17, 2002
Days to Decision 167 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
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - JEY Plate, Bone

All 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K022185.
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
K031761 · Synthes (Usa) · Sep 2003
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K030069 · Synthes (Usa) · Apr 2003
SYNTHES RESORBABLE CONTOURABLE MESH
K022844 · Synthes (Usa) · Jan 2003
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · Synthes (Usa) · Nov 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · Synthes (Usa) · Sep 2002
SYNTHES MIDFACE DISTRACTOR
K022005 · Synthes (Usa) · Sep 2002