# K140644: Procem

- Pathway: 510(k) (Traditional)
- Applicant: Ototronix, LLC
- Decided: Jun 19, 2014 after 98 days
- Product code: NEA (Cement, Ear, Nose And Throat)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K861369 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003567: Serenocem, Model BC 010, Corinthian Medical, Ltd. (2001)
- K080032: Envoycem, Model 1640, Envoy Medical Corporation (2008) Summary page 2.

## Indications for use
ProCemTM is intended for non-weight bearing applications in Otologic surgery, such as: 1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain. 2. Mechanical stabilization of middle ear and cochlear implants. 3. Attachment of middle ear implants to the ossicular bones.

Source page: https://510kreport.com/device/K140644
Methodology: https://510kreport.com/methodology