(28 days)
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
- Correction of varus, valgus, functional 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 fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques*
- Trauma
- Revision of previously failed total joint arthroplasty
*Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component.
These devices are single use implants.
These devices are for cemented use only.
The Orthopedic Salvage System- OSS offers a variety of component options for the treatments, as well as, resurfacing components for the proximal tibial and distal femur.
The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for a medical device (Orthopedic Salvage System - OSS Bodies-Proximal Tibial Sleeve) seeking clearance from the FDA. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Specifically, the "Non-Clinical Testing" section states: "An engineering analysis was performed on the modified and predicate Non-Cliffical resultig. An engineering andrysis was possible was functional within its intended use." This indicates some form of engineering analysis, but it doesn't detail acceptance criteria or a study designed to meet them.
The "Clinical Testing" section explicitly states: "Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing." This confirms that no clinical studies were performed for this submission.
Therefore, I cannot provide the requested information.
§ 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.