(126 days)
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
- Correction of varus, valgus or post traumatic deformity
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies
- Tumor resections
- Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
- Revision of previously failed total joint arthroplasty
- Trauma
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA)
When used with Biomet's Compress Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the distal end of the femur including the knee articulating surface. The Proximal Femoral Bodies with a Compress® Female Taper are designed to replace the proximal end of the femur including the hip articulating surface. These components are intended for use with Biomet's Compress® Segmental Femoral and Orthopedic Salvage Systems. The new devices that are the subject of this 510(k) have a taper bore that is directly compatible with the taper of the Compress spindle eliminating the need for a taper adapter and allowing for smaller resection lengths.
This document is a 510(k) summary for a medical device (orthopedic implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states:
- "Non-Clinical Testing: None provided as a basis for substantial equivalence."
- "Clinical Testing: None provided as a basis for substantial equivalence."
Instead, this 510(k) relies on demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is considered as safe and effective as existing devices without requiring new clinical trials or performance studies against specific acceptance criteria.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.