# K140226: Otis-C-Plus, Neotis Plate, Screw 06.5

- Pathway: 510(k) (Traditional)
- Applicant: Science For Biomaterials
- Decided: Jun 3, 2014 after 125 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: 3 generations back to K973812 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100604: Otis -C Plus, Sciences ET Bio Materiaux (Sbm) (2010) Summary page 1.
- K120818: Otis-C Plus, Science For Biomaterials (2012) Summary page 1.

## Indications for use
NEOTIS Plate Is Intended to be used In conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

Source page: https://510kreport.com/device/K140226
Methodology: https://510kreport.com/methodology