Cleared Special

Stryker Resorbable Fixation System (K213777) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213777 · Stryker Leibinger Micro Implants · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
63d
Days
Class 2
Risk

K213777 is an FDA 510(k) clearance for the Stryker Resorbable Fixation System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Leibinger Micro Implants (Portage, US). The FDA issued a Cleared decision on February 4, 2022 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Leibinger Micro Implants devices

Submission Details

510(k) Number K213777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2021
Decision Date February 04, 2022
Days to Decision 63 days
Submission Type Special
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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 K213777.
Tandry CMF Plate System
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Universal CMF System
K221855 · Stryker Leibinger GmbH & Co KG · Nov 2022
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K210731 · KLS-Martin L.P. · Jul 2022
Biomet Microfixation OmniMax MMF System
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OsteoSync™ Ti Dental Mesh
K202918 · Sites Medical, LLC · Jul 2021
TECHFIT Patient-Specific Maxillofacial System
K203282 · Industrias Medicas Sampedro S.A.S · May 2021