# K212608: RibFix Blu Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Apr 22, 2022 after 248 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: 15 generations back to K761228 (1976). 45 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162974: Biomet Microfixation RibFix Blu Thoracic Fixation System, Biomet Microfixation (2016) Summary page 4.

## Most influential descendants
- K261892: ProRib Fixation System (2026), 0 descendants of its own
- K261054: RibPlate System (2026), 0 descendants of its own
- K252166: RIB LINK™ Fixation System (2026), 0 descendants of its own
- K241282: RibFix Titan™ Fixation System (2024), 0 descendants of its own

## Indications for use
The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.

Source page: https://510kreport.com/device/K212608
Methodology: https://510kreport.com/methodology