# K172698: G-Beam Fusion Beaming System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Feb 7, 2018 after 153 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962616 (1996). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140741: Salvation Beams and Bolts System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System, Extremity Medical, LLC (2017) Summary page 4.

## Indications for use
The G-Beam™ Fusion Beaming System is intended to be inserted in the bones of the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions. It is indicated for fracture and osteotomy fixation, reconstruction procedures, non-unions and fusions of bones of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus. Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).

Source page: https://510kreport.com/device/K172698
Methodology: https://510kreport.com/methodology