Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Fine Osteotomy disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.
Fine Osteotomy is a patient-specific device.
The Fine Osteotomy™ System is an orthopedic fixation system used to stabilize bone fragments during corrective osteotomies of the distal femur or proximal tibia. The system supports proper alignment and promotes bone healing through rigid internal fixation.The system includes:Metallic bone plates (femoral and tibial) in open- and closed-wedge configurations.Bone screws compatible with the plates.Reusable surgical instruments for positioning and fixation.The plates and screws are made of titanium alloy Ti-6Al-4V ELI, a biocompatible material widely used in orthopedic implants.
The closed-wedge plates now include an oblong hole to enable controlled axial compression at the osteotomy site. An additional glass-bead-blasted surface finish for the plates has been validated to meet the same smoothness requirement as the existing polished finish.The plates are low-profile, anatomically contoured, and fixed with compatible self-tapping screws. The device functions as a load-sharing internal fixation system to maintain alignment during healing.
N/A
Ask a specific question about this device
Page 1 of 1