# K261892: ProRib Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Costa Surgical, Inc.
- Decided: Sep 23, 2026 after 110 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). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 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 5.
- K212608: RibFix Blu Thoracic Fixation System, Biomet Microfixation (2022) Summary page 5.
- K222397: KLS Martin Level One Rib Fixation System, KLS-Martin L.P. (2023) Summary page 5.

## Indications for use
The ProRib Fixation System extrathoracic plates and locking screws are 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. The ProRib Fixation System intrathoracic implants are indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Source page: https://510kreport.com/device/K261892
Methodology: https://510kreport.com/methodology