# K241282: RibFix Titan™ Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical
- Decided: Aug 19, 2024 after 104 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: 16 generations back to K761228 (1976). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203474: Biomet Microfixation RibFix Advantage System, Biomet Micofixation (2021) Summary page 4.
- K212608: RibFix Blu Thoracic Fixation System, Biomet Microfixation (2022) Summary page 4.

## Indications for use
The RibFix Titan Fixation System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Source page: https://510kreport.com/device/K241282
Methodology: https://510kreport.com/methodology