(22 days)
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; 5) revision of previously failed total hip arthroplasty due to recurrent dislocations.
The predicate Mallory-Head Modular Calcar was originally Device Deseription. The presented use. The distal stem has been modified by encared in 10-15-15 110 read/machined process to the male portion of the Morse applying a ron nardened massimal and distal portions of the stem. The prodicate locking taper that joins are pade of the same and have the same surface finishes and indications for use as well as the same lengths and configurations. These and indications for ass are interchangeable with all of Biomet's modular hip modified distal blems are liters. the proximal body and the distal stem are joined by means of a Morse locking taper.
The provided document, K000335, is a 510(k) premarket notification for the "Mallory-Head Modular Calcar Total Hip" system. It describes the device, its indications for use, and potential risks. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance data against predefined acceptance criteria from a specific clinical or performance study.
Therefore, I cannot provide the requested information from this document. The document primarily confirms that the FDA has determined the device is substantially equivalent to existing devices and can be marketed. It does not include:
- A table of acceptance criteria and reported device performance: This type of information would be found in a performance study report, which is not present here.
- Sample size used for the test set and data provenance: Not applicable as a performance study against acceptance criteria is not detailed.
- Number of experts used to establish ground truth and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
For medical device approvals, performance data and acceptance criteria are typically found in more detailed technical reports, clinical study summaries, or test reports that would be referenced or summarized in a comprehensive premarket application (like a PMA) or potentially in supporting documentation for a 510(k) that is not included in this high-level summary.
§ 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.