# K152463: SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Poriferous, LLC
- Decided: Jan 20, 2016 after 145 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: 6 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)
- K143173: Stryker CMF MEDPOR Customized Implant, Stryker (2015) Summary page 4.
- K140437: SU-Por Surgical Implant, Poriferous, LLC (2014) Summary page 4.

## Indications for use
SU-POR Patient-Specific Surgical Implant in Customized shapes to meet the needs of Individual patients are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. SU-POR Patient-Specific Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillifacial skeleton.

Source page: https://510kreport.com/device/K152463
Methodology: https://510kreport.com/methodology