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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:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. 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:

1. patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
2. surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications; and,
3. 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:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. 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:

1. patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
2. surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications; and,
3. 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.

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