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 Implant 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 Implant is either a rough titanium plasma spray or porous mesh/lattice surface to facilitate fast and solid “bone ingrowth” osseointegration.
Then a cutaneous stoma is created and the transcutaneous Adapter component of BADAL X™ is attached to the Implant with the M6 Locking Screw. In exceptional cases where there is few soft tissue coverage of the residual bone, BADAL X™ may be installed in a single surgical procedure. 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 | Sizes |
| 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 | 8 sizes: 8 diameters (Ø15mm to Ø 22mm) and 140 mm length |
| Implant OFI-Y | Custom made press fit intramedullary fixation rod for short femur | Ti6Al7Nb ISO 5832-11 stem with mesh surface layer or 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 | custom made according to the femur remnant dimensions on CT |
| 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 | custom made according to the tibia remnant dimensions on CT |
| Lag screw | To be used in combination with OFI-Y | Ti6Al7Nb | 5 sizes: diameter 10.45mm and 5 lengths (65mm to 85mm) |
| Transverse screw | To be used in combination with OTI | Ti6Al7Nb | 13 sizes: diameter 4.95mm and 13 lengths; (40mm to 100mm) |
| 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 | 5 sizes; 1 diameter 18.0mm and 5 lengths; (70mm to 110mm) |
| M6 Locking screw | Used to fasten Adapter to implant | Ti6Al7Nb | 1 size |
| Luci Connector | Quick-attach-and-release component to connect Adapter with artificial limb | Ti6AlV4, stainless steel, bronze | 1 size |
| Luci Offset Plates | … | Ti6AlV4 | 11 sizes: 0mm, 10mm, 20mm, 30mm, 30mm kink, 40mm, 40mm kink, 50mm, 50mm kink, 60mm, 60mm kink |
| Orbis Stoma Cap | stoma protection cap | silicone | 1 size |
| Luci Night Cap | Cap for Luci male part | PETG and silicone | 1 size |
| M14 Abutment screw | Used to fasten Connector to Adapter | Ti6Al7Nb | 1 size |
Device Design
BADAL X™ is designed by incremental innovation and clinical testing based on existing and well-established cementless orthopedic implants. The design and metal alloys of all bone anchoring systems for artificial limbs are adopted from existing uncemented press fit hip implants. A bone anchoring system of an artificial limb can be seen as an inverted stem of uncemented press hip implant. The aspect that makes this device unique and incomparable with a hip implant is that it protrudes through the skin. The transcutaneous fixation with possible pin tract complications is responsible for a different risk-benefit profile than hip implants.
The design of the BADAL X™ Implants is dictated by the dimensions and anatomy of the intramedullary canal of the femur and tibia.
The OFI-C femur Implant is slightly curved to match with the physiological curvature of the femur.
The custom made OFI-Y femur implant has one, 125 degrees 10.5mm diameter, oblique hole which is used to insert a canulated 10.45mm diameter OFI-Y lag screw in the hip neck to provide extra mechanical stability.
The custom made OTI tibia implant has one or two 5mm diameter holes for 4.95mm diameter Transverse Screw. The anatomical shape of the implant is patient specific designed to match exactly with the cross-sectional shape of the intramedullary space of the tibia.