# K211514: Longeviti PorousFit implant

- Pathway: 510(k) (Traditional)
- Applicant: Longeviti Neuro Solutions, LLC
- Decided: Jul 15, 2021 after 59 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123908: Omnipore Surgical Implants and Accessories, Matrix Surgical USA (2013) Summary page 4.

## Indications for use
Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.

Source page: https://510kreport.com/device/K211514
Methodology: https://510kreport.com/methodology