# K140437: SU-Por Surgical Implant

- Pathway: 510(k) (Traditional)
- Applicant: Poriferous, LLC
- Decided: Jun 13, 2014 after 112 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922489 (1992). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla, Porex Technologies Corp. (1992) Summary page 1.
- K123908: Omnipore Surgical Implants and Accessories, Matrix Surgical USA (2013) Summary page 1.

## Most influential descendants
- K160988: Biopor, AOC Porous Polyethylene, Cerepor (2016), 0 descendants of its own
- K152463: SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (2016), 0 descendants of its own

## Indications for use
Su-Por Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing aplications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. Su-Por Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Source page: https://510kreport.com/device/K140437
Methodology: https://510kreport.com/methodology