# K101930: Memometal Navis Bone Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Memometal Technologies
- Decided: Mar 15, 2011 after 249 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962616 (1996). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 1.
- K050512: Stryker Locked Plating System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 1.

## Indications for use
The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.

Source page: https://510kreport.com/device/K101930
Methodology: https://510kreport.com/methodology