Cleared Special

MEDPOR Customized Implant Kit

K254233 · Stryker Leibinger GmbH & Co KG · General & Plastic Surgery
Mar 2026
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K254233 is an FDA 510(k) clearance for the MEDPOR Customized Implant Kit, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Stryker Leibinger GmbH & Co KG (Frieburg, DE). The FDA issued a Cleared decision on March 12, 2026, 73 days after receiving the submission on December 29, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K254233 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2025
Decision Date March 12, 2026
Days to Decision 73 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FWP — Prosthesis, Chin, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3550

Similar Devices — FWP Prosthesis, Chin, Internal

All 65
FITme Customized Silicone Implant
K232593 · Keosan Trading Co. · Nov 2023
Customized Contour Implant
K200610 · Implantech Associates, Inc. · Dec 2020
Customized Contour Implant
K191130 · Implantech Associates, Inc. · Aug 2019
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916 · Stryker Leibinger GmbH & Co KG · Aug 2019
Stryker CMF MEDPOR Customized Implant
K153508 · Stryker · Feb 2016
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
K152463 · Poriferous, LLC · Jan 2016

More from Stryker Leibinger GmbH & Co KG

View all
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
SternalPlate Expansion
K243491 · HRS · Dec 2024
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