# K153573: Converge

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Enterprises, Inc.
- Decided: Aug 11, 2016 after 240 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: 4 generations back to K983495 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092493: GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System, Gpc Medical, Ltd. (2010) Summary page 4.

## Indications for use
The Converge™ is indicated for fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulna, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

Source page: https://510kreport.com/device/K153573
Methodology: https://510kreport.com/methodology