Device Dossier
OSS Hybrid Poly Tibial Component - Uncoated knee tibia prosthesis, metallic
Device Dossier for OSS Hybrid Poly Tibial Component - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III,…
- GMDN category: Uncoated knee tibia prosthesis, metallic
Intended purpose
OSS Hybrid Poly Tibias are part of the Biomet OSS Orthopaedic Salvage System, and is indicated for: 1.Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies. 5. Tumor resections. 6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 7. Revision of previously failed total joint arthroplasty. 8. Trauma.
Functional description
The OSS Hybrid Poly tibial component utilize a polyethylene stem that is mechanically locked to the metallic baseplate. These components will primarily be used in adolescent patients that have an open epiphysis. Manufactured from ArCom UHMWPE and Co-Cr-Mo alloy. Intended for cemented use.