# K140875: Optossol Compression Device System

- Pathway: 510(k) (Traditional)
- Applicant: Genossis, LLC
- Decided: May 30, 2014 after 56 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K962823 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130298: Biopro Kwick-Wire Universal Screw System, Biopro, Inc. (2013) Summary page 2.

## Indications for use
The Optassolm Compression Device System Is indicated for use in the Internal fixation of fractures, fusions and revisions. The system Is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not Intended for Spinal Use.

Source page: https://510kreport.com/device/K140875
Methodology: https://510kreport.com/methodology