# K170410: Longeviti PMMA Static Cranial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Longeviti Neuro Solutions, LLC
- Decided: Mar 23, 2018 after 406 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
Longest line of descent: 4 generations back to K904111 (1990). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133082: Osteosymbionics Patient-Specific Cranial Plate, Osteosymbionics, LLC (2014) Summary page 4.
- K072601: Osteosymbionics Patient Specific Cranial Implant, Osteosymbionics, LLC (2007) Summary page 4.

## Most influential descendants
- K191210: Longeviti ClearFit Cranial Implant (2020), 3 descendants of its own
- K203349: Longeviti ClearFit Cranial Implant (2020), 2 descendants of its own
- K231920: Longeviti ClearFit OTS Cranial Implant (2023), 1 descendant of its own
- K260709: ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) (2026), 0 descendants of its own

## Indications for use
The Longeviti Static Cranial Implants are designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.

Source page: https://510kreport.com/device/K170410
Methodology: https://510kreport.com/methodology