# K231649: Intraosseous Fusion Device System

- Pathway: 510(k) (Traditional)
- Applicant: Auxano Medical, LLC
- Decided: Sep 29, 2023 after 115 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). 212 ancestors in all.
No later device cites it as a predicate yet.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191995: S4 Screw System, Subchondral Solutions, Inc. (2020) Summary page 4.
- K163489: OrthoSolutions 'System26' Bone Screws, Ortho Solutions UK Limited (2017) Summary page 4.

## Indications for use
The Intraosseous Fusion Device System is indicated for use in skeletally mature individuals for fracture repair and arthrodesis, osteotomy, joint fusion and fragment fixation appropriate with the size of the implant including: Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus. The Intraosseous Fusion Device System is not intended for spinal use.

Source page: https://510kreport.com/device/K231649
Methodology: https://510kreport.com/methodology