Cleared Traditional

Stryker Cutomized Mandible Recon Plate (K222650) - FDA 510(k) Clearance

Also marketed or referenced as:
Stryker Surgeon iD Mandible Recon Plate

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222650 · Stryker Craniomaxillofacial (Cmf) · Dental device
Download Printable Device Report (PDF)
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Dec 2022
Decision
99d
Days
Class 2
Risk

K222650 is an FDA 510(k) clearance for the Stryker Cutomized Mandible Recon Plate. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Craniomaxillofacial (Cmf) (Portage, US). The FDA issued a Cleared decision on December 9, 2022 after a review of 99 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 Craniomaxillofacial (Cmf) devices

Submission Details

510(k) Number K222650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2022
Decision Date December 09, 2022
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
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 95
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K222650.
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K210731 · KLS-Martin L.P. · Jul 2022