MEDPOR Customized Implant Kit
FDA 510(k) K254233 · Stryker Leibinger GmbH & Co KG
510(k) numberK254233
Submission
- Device name
- MEDPOR Customized Implant Kit
- Applicant
- Stryker Leibinger GmbH & Co KG
Frieburg, DE - Received
- December 29, 2025
- Decision date
- March 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232593 | FITme Customized Silicone ImplantFWP · Traditional | Keosan Trading Co. | 11/22/2023SE |
| K200610 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 08/23/2019SE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 08/15/2019SE |
| K153508 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 02/05/2016SE |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantFWP · Traditional | Poriferous, LLC | 01/20/2016SE |
| K143173 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 03/23/2015SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | Implantech Associates, Inc. | 07/10/2014SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | Howmedica Osteonics Corp. | 11/01/2012SE |
| K091011 | Pureform Eptfe Facial Implants (Nasal, Chin, Maler)FWP · Traditional | Surgical Technology Laboratories, Inc ("Stl") | 04/22/2009SE |
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Questions and answers
When was MEDPOR Customized Implant Kit cleared by the FDA?
MEDPOR Customized Implant Kit (K254233) received a 510(k) decision of Substantially Equivalent on March 12, 2026, 73 days after the submission was received.
What is the product code of K254233?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.