Device Dossier
LEGION HK Bolt and Sleeve Kit - Fixation device, internal, bolt
Device Dossier for LEGION HK Bolt and Sleeve Kit - Fixation device, internal, bolt (Orthopaedic bone bolt, Class III, sponsor Smith & Nephew). ARTG…
- GMDN category: Orthopaedic bone bolt
- Sponsor: Smith & Nephew
Intended purpose
The LEGION HK Hinge Knee System is intended to be used with bone cement. Indications for Total Knee Replacement are: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies or total knee replacement. 4. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent.
Functional description
A sterile cobalt chrome alloy bolt and sleeve inserted through the link assembly and into the tibial base. The bolt is tightened with a screwdriver and using a torque wrench and applying counter torque, is tightened and then impacted into place and finally, re-torqued again.