# K141644: Innovasis Cranial System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Nov 7, 2014 after 141 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953806 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112812: Leforte Neuro System Bone Plate, Jeil Medical Corporation (2012) Summary page 4.

## Indications for use
The Innovasis Cranial System is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

Source page: https://510kreport.com/device/K141644
Methodology: https://510kreport.com/methodology