(382 days)
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur/proximal tibia is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
This document is a 510(k) summary for a medical device (Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments) seeking to expand its indications for use. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it focuses on demonstrating substantial equivalence to previously marketed devices (a process for regulatory clearance, not clinical performance evaluation). The only "testing" mentioned is for "modular tapers," but no details on acceptance criteria or results are provided.
Therefore, I cannot provide the requested information from the given text.
Here's why and what's missing:
- Acceptance Criteria & Device Performance: The document states "A comparison to other legally marketed products was made, and testing of the modular tapers was presented." This is incredibly vague. It doesn't specify what the acceptance criteria for this testing were, nor does it present any numeric or descriptive performance data.
- Sample Size & Data Provenance (Test Set): No information is provided about any test set used to evaluate clinical or technical performance.
- Number & Qualifications of Experts (Ground Truth): No experts are mentioned in the context of establishing ground truth for performance evaluation.
- Adjudication Method: Not applicable as no ground truth establishment is described.
- MRMC Comparative Effectiveness Study: No such study is mentioned or implied. The device is a physical implant, not an AI/software device that would typically undergo MRMC studies for human-in-the-loop improvement.
- Standalone Performance Study: As above, no such study is mentioned for clinical performance. The focus is on demonstrating substantial equivalence based on materials and design comparison, and some unspecified "testing of modular tapers."
- Type of Ground Truth: Not applicable, as no performance study is detailed.
- Sample Size for Training Set: Not applicable, as this is a physical device approval, not a machine learning model.
- Ground Truth for Training Set: Not applicable.
In summary, the provided text describes a regulatory submission for expanding the indications of a medical implant and does not contain the detailed performance study information requested.
§ 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.