(23 days)
The Maxim Knee System is indicated for:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is for use with bone cement
The Maxim Knee femorals are composed of Co-Cr-Mo conforming to ASTM F-75 standards. The posterior stabilized femoral components provide stabilization in knees with soft tissue deficiencies. The devices achieve stability against posterior tibial subluxation through the posterior flange of the femoral component meeting a central polyethylene post on the tibial component. This configuration allows for minimal femoral femoral roll back and rotational instability. The modifications made to the anterior flange were the increase in height and the decrease in angle. The femoral augment holes are now threaded instead of unthreaded and material was removed from the anterior flange in the form of retinaculum relief.
There are six sizes available in both right and left configurations for the Maxim PS V-II femoral components as well as the Maxim PS w/ Retinacular Relief femoral components. The femoral articulation is the same as the Maximum Congruent Knee (K915132). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications.
This is a medical device submission (K993159) for the Maxim Knee System, a knee replacement prosthesis. The document does not describe acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new performance studies against predefined acceptance criteria.
Therefore, I cannot provide the requested information from the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This is a regulatory filing for a physical medical device (knee implant), not an AI/software as a medical device (SaMD) where such performance metrics and study designs would be typically found.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.