(108 days)
Mallory-Head® Modular Calcar Stems with Interlocking Slots are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
The Mallory-Head® Modular Calcar System consists of a variety of proximal metaphyseal segments and distal stems. This 510(k) was for a distal stem that has three medial/lateral slots located in the distal half of the device designed for cross screw placement. The proximal bodies and distal stems of the Mallory-Head® Modular Calcar System are joined by means of a Morse looking taper similar to that used to attach the modular head components to most hip stems. The cross-screws are available in lengths of 25mm to 60mm and 5mm diameters.
The provided text indicates that no clinical testing was performed to prove the device met acceptance criteria. Only non-clinical mechanical testing was conducted.
Therefore, the following information cannot be extracted:
- Table of acceptance criteria and reported device performance (as no clinical performance data is reported)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Non-Clinical Testing Summary:
- Acceptance Criteria/Testing Performed: Mechanical testing has been conducted to demonstrate the ability of the screws to survive physiological loading.
- Device Performance: The summary states "Mechanical testing has been conducted to demonstrate the ability of the screws to survive physiological loading," implying successful demonstration. However, specific performance metrics or acceptance thresholds for this mechanical testing are not provided in the document.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.