Device Dossier
UNITRAX Neck Adjustment Sleeve V40 - Femoral head/stem prosthesis adaptor
Device Dossier for UNITRAX Neck Adjustment Sleeve V40 - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor…
- GMDN category: Femoral head/stem prosthesis adaptor
- Sponsor: Stryker
Intended purpose
Intended for use in Hemi-hip replacement with the following indications: femoral neck fractures, idiopathic avascular necrosis, and nonunions. The patient’s acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis.
Functional description
A sterile metal sleeve used to fit the trunion of a V40 tapered Femoral Hip Stem, allowing the use of the UNITRAX Endoprostheisis head. Through the use of locking tapers, mallet blows cold weld the metal surfaces of the head, sleeve and trunnion. The resultant assembly functions in a similar fashion to a fixed head endoprosthesis.