# K022323: Normed Titanium Rondo Fix Fusion Plates and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Sep 9, 2002 after 54 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain andor loss of h c t i o n due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K022323
Methodology: https://510kreport.com/methodology