Cleared Special

SternalPlate Expansion

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

About This 510(k) Submission

K243491 is an FDA 510(k) clearance for the SternalPlate Expansion, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on December 11, 2024, 29 days after receiving the submission on November 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243491 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

Similar Devices — HRS Plate, Fixation, Bone

All 1291
Xpert Hand
K253906 · Newclip Technics · Mar 2026
DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System
K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System
K254054 · Synthes GmbH · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK? Fixation System
K252166 · Globus Medical, Inc. · Feb 2026

More from Stryker Leibinger GmbH & Co KG

View all
MEDPOR Customized Implant Kit
K254233 · FWP · Mar 2026
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
K253623 · OLO · Feb 2026
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
K252871 · OLO · Feb 2026
Q Guidance System; Mako Spine System;
K241517 · OLO · Aug 2024
Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories
K241171 · OLO · Jul 2024