# K210616: Longeviti PMMA Static Cranial Implant

- Pathway: 510(k) (Special)
- Applicant: Longeviti Neuro Solutions, LLC
- Decided: Mar 31, 2021 after 30 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Longeviti ClearFit Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defect of the cranium.

Source page: https://510kreport.com/device/K210616
Methodology: https://510kreport.com/methodology