BADAL X™ (Bone Anchoring Device for Artificial Limbs) components
- Implant (OFI-C, OFI-Y, OTI)
- Adapter (DCA)
- Luci Connector
Intended use
BADAL X™ is intended to provide a fixed support for the connection of an artificial limb to the residual bone after lower limb amputation in persons with serious complaints associated with the use of a conventional socket attached artificial limb. BADAL X™ is a non-active surgical device designed for long-term implantation inside the human body. It is intended to be used by (orthopaedic-) surgeons with good knowledge of the specific surgical technique, in a standard orthopaedic environment, for skeletally mature subjects that comply to the in- and exclusion criteria.
BADAL X™ can be installed preferably in a single surgical procedure under spinal or general anesthesia.
First the Stem is installed into the diaphysis of the bone remnant of the lower limb by retrograde approach. The installation of Implant is press-fit to provide a primary stability for osseointegration. The surface of the Stem is a rough titanium plasma spray to facilitate fast and solid “bone ingrowth” osseointegration.
Then a cutaneous stoma is created and the Adapter component of BADAL X™ is attached to the Implant with the M6 Locking Screw. After the surgery the LUCI Connector is attached to the Adapter with a M14 Abutment Screw to allow a quick-attach-and-release connection of BADAL X™ with an artificial limb.
| BADAL X™ Component | Property | Specifications |
| Implant OFI-C | Curved press fit intramedullary fixation rod for long femur | Ti6Al7Nb ISO 5832-11 Distal part of the stem is Titanium Plasma Spray coated.The distal head is mirror polished and TiNbN coated |
| Implant OFI-Y | Custom made press fit intramedullary fixation rod for short femur | Ti6Al7Nb ISO 5832-11 stem with titanium plasma spray coating and proximally provided with a 125 degrees oblique 10.5mm diameter hole. The distal head is mirror polished and TiNbN coated |
| Implant OTI | Custom made press fit intramedullary fixation rod | Ti6Al7Nb ISO 5832-11 stem with mesh or titanium plasma sprayed surface layer. The proximal part has one or two 5.0mm diameter holes. The distal head is mirror polished and TiNbN coated |
| Collum screw | To be used in combination with OFI-Y | Ti6Al7Nb |
| DCA | Straight cylindrical rod with on both ends two 16/18 morse tapers for transcutaneous adaptation of implant with connector | Ti6Al7Nb. The cylindrical part is mirror polished and TiNbN coated |
| M6 Locking screw | Used to fasten Adapter to implant | Ti6Al7Nb |
| Luci Connector | Quick-attach-and-release component to connect Adapter with artificial limb | Ti6AlV4, stainless steel, bronze |
| Luci Offset Plates | … | Ti6AlV4 |
| Orbis Stoma Cap | stoma protection cap | silicone |
| Luci Night Cap | Cap for Luci male part | PETG and silicone |
| M14 Abutment screw | Used to fasten Connector to Adapter | Ti6Al7Nb |