(88 days)
The indications for use for the GUARDIAN™ Limb Salvage System will be substantially equivalent to the indication for use listed under competitive devices previously cleared for market and identical to the indication for use previously submitted under Lacey Rotating Hinge Knee, DCW Modular Distal Femoral System, and. S.O.S.™ Proximal Femur.
GUARDIAN™ Limb Salvage Hip Components:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions:
- patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
- surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications; and,
- matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors).
The GUARDIAN™ Limb Salvage Knee Components:
Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of fractures that are unmanageable using other techniques.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:
- patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
- surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications; and,
- matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors).
The GUARDIAN™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The components are femoral neck, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial sleeve spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia.
This document is a 510(k) summary for the GUARDIAN™ Limb Salvage System, submitted by Wright Medical Technology, Inc. in 2001. Unfortunately, the provided text does not contain details about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Identification of the device and submitter.
- Intended Use and Indications for Use for the GUARDIAN™ Limb Salvage Hip Components and Knee Components, detailing various degenerative joint diseases, traumatic arthritis, avascular necrosis, and oncology indications for which the system is intended.
- Device Description, outlining the various components and their reconstruction applications (proximal femur, distal femur, total femur, proximal tibia, and hinged knee).
- Substantial Equivalence Information, stating that the device is substantially equivalent to competitive devices previously cleared for market based on intended use, material, type of interface, and design features. It also mentions that safety and effectiveness are supported by substantial equivalence information, materials data, and testing results provided within the Premarket Notification (which is not included here).
- FDA's 510(k) clearance letter, which grants permission to market the device based on substantial equivalence.
Without further information from the full Premarket Notification, it is not possible to answer your specific questions regarding acceptance criteria and performance studies. These types of details would typically be found in dedicated sections of a 510(k) submission, such as performance testing summaries or biocompatibility reports, which are not present in this summary.
§ 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.