Cleared Traditional

K231599 - Stryker MP

K231599 is the FDA 510(k) clearance for Stryker MP by Stryker Leibinger GmbH & Co KG. It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K231599 · Stryker Leibinger GmbH & Co KG · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
84d
Days
Class 2
Risk

K231599 is an FDA 510(k) clearance for the Stryker MP, Mandible, HMMF and MMF AXS Screws. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on August 24, 2023 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Leibinger GmbH & Co KG devices

Submission Details

510(k) Number K231599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2023
Decision Date August 24, 2023
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K231599.
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