Customized cutting guides are designed to exactly match a patient's anatomy, while reproducing the pre-operative planning parameters. Femoral and tibial guides are made for the knee, along with a trial (bone model) if requested by the surgeon. These polyamide (PA 2200) guides are biocompatible and can be sterilized in an autoclave. They are produced using Selective Laser Sintering (SLS) technology.
The OneFit Knee Planner is used to perform pre-operative planning for total knee arthroplasty (TKA) cases. This is an interactive, ergonomic tool that allows for virtual collaboration. It is used to determine optimal implant positioning before the surgery. Various positional and rotational references can be used, depending on the surgeon's preferences. This software allows the various process contributors to participate in and monitor the TKA implantation.
This innovative technique consists of several steps performed before the surgery:
510(k)Pending / CE marked
|MRI Protocol||CT-Scan Protocol|
- Regulatory manufacturer: ONEFIT medical ;
- Custom guides: custom medical device (according to European directive 93/42/EEC) ;
- Planning software: class I medical device with measuring function (according to European directive 93/42/EEC) – CE 0459 marked by LNE/G-MED ;
Consult operating instructions.