Cleared Traditional

K221855 - Universal CMF System

K221855 is the FDA 510(k) clearance for Universal CMF System by Stryker Leibinger GmbH & Co KG. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K221855 · Stryker Leibinger GmbH & Co KG · Dental device
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Nov 2022
Decision
135d
Days
Class 2
Risk

K221855 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 Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on November 9, 2022 after a review of 135 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 Leibinger GmbH & Co KG devices

Submission Details

510(k) Number K221855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2022
Decision Date November 09, 2022
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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 K221855.
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K202969 · Biomet Microfixation · Aug 2021