# K254233: MEDPOR Customized Implant Kit

- Pathway: 510(k) (Special)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Mar 12, 2026 after 73 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904111 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191916: Stryker CMF MEDPOR Priority Customized Implant Kit, Stryker Leibinger GmbH & Co KG (2019) Summary page 6.

## Indications for use
The CMF MEDPOR® Customized Implant is indicated for the augmentation, and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

Source page: https://510kreport.com/device/K254233
Methodology: https://510kreport.com/methodology