Cleared Special

K243491 - SternalPlate Expansion

K243491 is the FDA 510(k) clearance for SternalPlate Expansion by Stryker Leibinger GmbH & Co KG. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 29-day FDA review.

K243491 · Stryker Leibinger GmbH & Co KG · Orthopedic device
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Dec 2024
Decision
29d
Days
Class 2
Risk

K243491 is an FDA 510(k) clearance for the SternalPlate Expansion. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on December 11, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic 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 GmbH & Co KG devices

Submission Details

510(k) Number K243491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date December 11, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K243491.
TriMed Wrist Fixation System (Volar Bearing Plates)
K243569 · TriMed, Inc. · Jan 2025
ARTFX Trauma Bone Plate and Screw System
K242939 · Artfx Medical · Dec 2024
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K243308 · Bonebridge AG · Dec 2024
TDM Plate and Screw System
K241128 · Tdm Co., Ltd. · Dec 2024
HyperFlex™ Bunion Correction System
K241995 · Footbridge Medical · Nov 2024
TriMed Posterior Malleolus Fixation System
K243050 · TriMed, Inc. · Nov 2024