Stryker CMF MEDPOR Priority Customized Implant Kit
FDA 510(k) K191916 · Stryker Leibinger GmbH & Co KG
510(k) numberK191916
Submission
- Device name
- Stryker CMF MEDPOR Priority Customized Implant Kit
- Applicant
- Stryker Leibinger GmbH & Co KG
Freiburg, DE - Received
- July 17, 2019
- Decision date
- August 15, 2019
- 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 |
|---|---|---|---|
| K254233 | MEDPOR Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 03/12/2026SE |
| 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 |
| 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 |
More from Surgical Technology Laboratories, Inc ("Stl")
| 510(k) | Device | Decision |
|---|---|---|
| K261054 | RibPlate SystemHRS · Traditional | 07/01/2026SE |
| K254233 | MEDPOR Customized Implant KitFWP · Special | 03/12/2026SE |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…OLO · Traditional | 02/19/2026SE |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…OLO · Traditional | 02/06/2026SE |
| K243491 | SternalPlate ExpansionHRS · Special | 12/11/2024SE |
| K241517 | Q Guidance System; Mako Spine System;OLO · Traditional | 08/27/2024SE |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…OLO · Traditional | 07/25/2024SE |
| K240651 | MRI UniversalJEY · Traditional | 07/12/2024SE |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…OLO · Traditional | 06/06/2024SE |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…OLO · Traditional | 03/14/2024SE |
Questions and answers
When was Stryker CMF MEDPOR Priority Customized Implant Kit cleared by the FDA?
Stryker CMF MEDPOR Priority Customized Implant Kit (K191916) received a 510(k) decision of Substantially Equivalent on August 15, 2019, 29 days after the submission was received.
What is the product code of K191916?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.