Search Results

The Avon™ Patello-femoral Joint Replacement is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

The Avon™ Patello-femoral Joint Prosthesis is intended to be used in the replacement of the patellofemoral joint in patients with degenerative arthritis of the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. The current system consists of cobaltchromium femoral components available in three sizes (small, medium, and large), and allpolyethylene components available in three sizes (small, medium, and large). These components are intended to be implanted using bone cement. It is the intention of Stryker Howmedica Osteonics to introduce an extra-small Avon™ Patellofemoral replacement component. The extra-small Avon™ femoral component differs from the previously released small Avon™ femoral component in the following ways: 1. The width of the patellar flange is reduced by 3mm (small 46.5mm; extra-small: 43.5mm) 2. The intra-condylar distal flange hcight is reduced by 1.5mm (small 19.5; extra-small 18.0mm) This component is also intended to be implanted using bone cement. The Avon™ Extra-Small Patello-femoral Replaccment component is a single-use device intended for replacement of the femoral side of the patello-femoral joint.

The provided text describes a medical device submission (K041160) for a "Line Extension to Avon™ Patello-femoral Replacement System - Extra-Small Femoral Component." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC studies.

Instead, it describes changes made to an existing, cleared device (Avon™ Patello-femoral Joint Prosthesis, cleared in K010100 and K020841) to introduce an "extra-small" size. The justification for clearance is based on the technological comparison to the predicate device, specifically highlighting the dimensional changes in the extra-small femoral component:

• 1. The width of the patellar flange is reduced by 3mm (small 46.5mm; extra-small: 43.5mm)
• 2. The intra-condylar distal flange height is reduced by 1.5mm (small 19.5; extra-small 18.0mm)

The FDA's letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is based on the comparison to the predicate, not on a new clinical study with specific performance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document's purpose is to show equivalence through design comparison, not to present a new study with acceptance criteria for device performance.

Ask a specific question about this device