# K120818: Otis-C Plus

- Pathway: 510(k) (Special)
- Applicant: Science For Biomaterials
- Decided: Apr 19, 2012 after 31 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: 2 generations back to K973812 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K140226: Otis-C-Plus, Neotis Plate, Screw 06.5 (2014), 0 descendants of its own

## Indications for use
OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomnies

Source page: https://510kreport.com/device/K120818
Methodology: https://510kreport.com/methodology